recall_number string | recall_type string | firm_name string | product_description string | reason_for_recall string | status string | recall_class null | initiation_date date32 | report_date date32 | distribution_pattern string | product_quantity string | product_ndc string | fei_number string | facility_total_inspections float64 | facility_oai_count float64 | facility_last_classification string | facility_last_inspection date32 | facility_compliance_actions int64 | facility_warning_letters int64 | last_compliance_action_date date32 | preceded_by_oai bool | days_since_last_inspection float64 | failure_category string | failure_subcategory string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
D-0273-2025 | drug | Denison Pharmaceuticals, LLC | Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1 | Chemical Contamination: Presence of benzene. | Ongoing | null | 2025-02-24 | 2025-03-19 | Nationwide within the USA | 642,131 tubes | 71687-0011 | 3012228456 | 1 | 0 | Voluntary Action Indicated (VAI) | 2016-04-05 | 0 | 0 | null | false | 0 | contamination | benzene presence |
Z-0472-2017 | device | ICU Medical, Inc. | RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure ... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Terminated | null | 2016-09-27 | 2016-11-23 | null | 125 units | null | 3013319212 | 8 | 2 | No Action Indicated (NAI) | 2024-09-09 | 2 | 2 | 2013-05-09 | false | -1 | device_malfunction | potential leak |
Z-1187-2026 | device | Medline Industries, LP | Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034; | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive. | Ongoing | null | 2025-12-12 | 2026-02-04 | null | 1,928 total | null | 3015077251 | 1 | 0 | No Action Indicated (NAI) | 2024-04-24 | 0 | 0 | null | false | 0 | device_malfunction | tubing cracking defect |
Z-2553-2014 | device | Siemens Healthcare Diagnostics, Inc. | Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338. | The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator. | Terminated | null | 2014-07-16 | 2014-09-03 | null | 2757 | null | 1219913 | 8 | 1 | Voluntary Action Indicated (VAI) | 2022-03-08 | 1 | 1 | 2012-05-10 | false | -1 | device_malfunction | hinge failure risk |
D-1595-2019 | drug | Herbal Doctor Remedies | Dragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Terminated | null | 2019-07-12 | 2019-08-14 | Nationwide within the United States and Brazil and on the internet | N/A | null | 3003040962 | 3 | 1 | No Action Indicated (NAI) | 2018-05-22 | 2 | 2 | 2019-10-04 | false | 0 | cGMP | manufacturing controls |
Z-0836-2018 | device | Stryker Corporation | STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620); | Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. | Terminated | null | 2017-11-17 | 2018-03-14 | null | 60,753 units total | null | 3006011135 | 1 | 0 | Voluntary Action Indicated (VAI) | 2010-09-24 | 0 | 0 | null | false | 0 | sterility | elevated bioburden levels |
Z-0493-2015 | device | Bard Access Systems | GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006. | Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they were non-sterile unit samples which potentially could be used clinically. | Terminated | null | 2014-11-03 | 2014-12-10 | null | 2532 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | non-sterile units |
Z-0001-2019 | device | Smith & Nephew, Inc. | Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229 | The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class ave... | Ongoing | null | 2018-06-13 | 2018-10-10 | null | 10,792 units | null | 3007282753 | 2 | 0 | No Action Indicated (NAI) | 2017-07-24 | 0 | 0 | null | false | 0 | device_malfunction | elevated revision rate |
Z-3397-2018 | device | B. Braun Medical, Inc. | EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous admini... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed. | Terminated | null | 2018-07-20 | 2018-10-10 | null | 16400 | null | 3014301563 | 1 | 0 | Voluntary Action Indicated (VAI) | 2018-12-27 | 0 | 0 | null | false | -1 | device_malfunction | connector closure failure |
Z-1328-2017 | device | Windstone Medical Packaging, Inc. | Lap Pack, part number AMS4801 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility. | Terminated | null | 2017-01-11 | 2017-03-08 | null | 36 kits | null | 1000125955 | 2 | 0 | No Action Indicated (NAI) | 2019-06-21 | 0 | 0 | null | false | -1 | sterility | compromised glove integrity |
Z-0211-2026 | device | Cardinal Health 200, LLC | Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264432 Salem Sump" PVC Gastroduodena... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214. | Ongoing | null | 2025-09-18 | 2025-10-29 | null | all lots | null | 3002973487 | 3 | 0 | No Action Indicated (NAI) | 2015-07-20 | 0 | 0 | null | false | 0 | device_malfunction | valve breakage |
Z-0680-2024 | device | Abbott Laboratories | Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | Ongoing | null | 2023-10-19 | 2024-01-17 | null | 1,325 systems | null | 3013324964 | 9 | 0 | No Action Indicated (NAI) | 2025-08-01 | 0 | 0 | null | false | -1 | undeclared_allergen | latex allergen |
Z-0471-2026 | device | Medline Industries, LP | Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. | Ongoing | null | 2025-10-01 | 2025-11-19 | null | 2 units | null | 3011508621 | 1 | 0 | Voluntary Action Indicated (VAI) | 2018-05-25 | 0 | 0 | null | false | 0 | device_malfunction | material entrapment |
Z-1881-2013 | device | Siemens Healthcare Diagnostics, Inc | ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Terminated | null | 2013-05-10 | 2013-08-14 | null | 172913 | null | null | null | null | null | null | 0 | 0 | null | false | null | potency | undetected TSH variant |
Z-1331-2023 | device | Medtronic Sofamor Danek USA Inc | Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. | Ongoing | null | 2023-02-08 | 2023-04-12 | null | 10037 units | null | 1000477302 | 11 | 0 | Voluntary Action Indicated (VAI) | 2015-11-03 | 0 | 0 | null | false | 0 | packaging | sterile barrier breach |
Z-1344-2014 | device | LumiQuick Diagnostics Inc. | Rotavirus Test Card LumiQuick, Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. | Terminated | null | 2014-03-04 | 2014-04-16 | null | ALL | null | 3005984081 | 5 | 1 | No Action Indicated (NAI) | 2025-11-05 | 2 | 2 | 2014-04-01 | false | -1 | other | unapproved device distribution |
Z-2157-2012 | device | Abbott Point Of Care Inc. | I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin. | The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. | Terminated | null | 2012-03-01 | 2012-08-15 | null | 2,950,296 cartridges US; 156,408 cartridges OUS | null | 2245578 | 2 | 0 | No Action Indicated (NAI) | 2017-09-20 | 0 | 0 | null | false | -1 | device_malfunction | incorrect test results |
Z-2553-2014 | device | Siemens Healthcare Diagnostics, Inc. | Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338. | The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator. | Terminated | null | 2014-07-16 | 2014-09-03 | null | 2757 | null | 3009448641 | 1 | 0 | No Action Indicated (NAI) | 2017-11-29 | 0 | 0 | null | false | -1 | device_malfunction | hinge failure risk |
Z-2164-2012 | device | Radiometer America Inc | ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood. | A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL... | Terminated | null | 2012-07-05 | 2012-08-15 | null | 1427 ABL 90 Instruments | null | 1523456 | 2 | 0 | Voluntary Action Indicated (VAI) | 2015-03-02 | 0 | 0 | null | false | -1 | software | HL7 data transmission |
Z-0674-2013 | device | Philips Medical Systems (Cleveland) Inc | Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body... | Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; devi... | Terminated | null | 2012-12-03 | 2013-01-23 | null | A total of nine (9) units were distributed (3 units in the U.S & 6 units overseas) | null | 1525965 | 10 | 2 | No Action Indicated (NAI) | 2019-11-26 | 1 | 1 | 2011-06-07 | false | -1 | software | CT scanner anomalies |
Z-2427-2025 | device | Boston Scientific Corporation | WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is u... | Ongoing | null | 2025-07-29 | 2025-09-10 | null | 340185 units in total | null | 3002095335 | 11 | 0 | No Action Indicated (NAI) | 2025-03-18 | 0 | 0 | null | false | 0 | device_malfunction | air embolism risk |
Z-3227-2024 | device | American Contract Systems, Inc. | Endovascular AAA Pack, ESED52B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. | Ongoing | null | 2024-08-07 | 2024-10-02 | null | 93 units | null | 3008493588 | 2 | 0 | No Action Indicated (NAI) | 2014-01-09 | 0 | 0 | null | false | 0 | cGMP | equipment failure monitoring |
Z-1669-2018 | device | Siemens Healthcare Diagnostics, Inc. | Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge | The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere. | Terminated | null | 2018-01-02 | 2018-05-16 | null | N/A | null | 2517506 | 4 | 1 | Voluntary Action Indicated (VAI) | 2014-04-23 | 1 | 1 | 2012-06-29 | false | 0 | mislabeling | incorrect instructions |
D-0757-2022 | drug | Pfizer Inc. | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23. | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Terminated | null | 2022-03-21 | 2022-04-13 | Nationwide | 265 bottles | null | 3001433984 | 2 | 0 | No Action Indicated (NAI) | 2025-08-22 | 0 | 0 | null | false | -1 | cGMP | N-nitroso impurity |
Z-0528-2018 | device | Angiodynamics, Inc. | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue. | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator. | Terminated | null | 2017-06-05 | 2018-02-14 | null | 14,353 units in total | null | 3017892510 | 10 | 0 | No Action Indicated (NAI) | 2021-06-25 | 0 | 0 | null | false | -1 | device_malfunction | coolant ingress failure |
D-1011-2013 | drug | Beacon Hill Medical Pharmacy, P.C. | Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Terminated | null | 2013-07-26 | 2013-09-18 | USA nationwide | N/A | null | 3009641885 | 1 | 1 | Official Action Indicated (OAI) | 2013-07-19 | 1 | 1 | 2014-09-24 | true | 0 | sterility | QC procedure deficiency |
Z-0701-2019 | device | Boston Scientific Corporation | IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent ... | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document. | Ongoing | null | 2018-11-28 | 2019-01-16 | null | 1,282 (all three types in Japan) | null | 1000116179 | 8 | 1 | No Action Indicated (NAI) | 2017-12-11 | 1 | 1 | 2014-04-10 | false | 0 | cGMP | unapproved supplier change |
D-335-2013 | drug | Performance Plus Marketing, Inc. | BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536 | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs | Terminated | null | 2012-12-17 | 2013-05-22 | Nationwide | 1,000 capsules. | null | null | null | null | null | null | 0 | 0 | null | false | null | other | unapproved drug marketed |
D-0095-2018 | drug | NEW RELIANCE TRADING, INC. | No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by NEW RELIANCE TRADING, INC., 5563 59th St., Maspeth, New York, 11378-2358, UPC 8993138993349, 5842109854239. | Marketed Without an Approved NDA/ANDA | Terminated | null | 2017-10-06 | 2017-12-06 | NY | 513 foil packets | null | null | null | null | null | null | 0 | 0 | null | false | null | other | unapproved marketing |
Z-1318-2017 | device | Windstone Medical Packaging, Inc. | Hystero Pack, part number PSS3535(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility. | Terminated | null | 2017-01-11 | 2017-03-08 | null | 32 kits | null | 1000125955 | 2 | 0 | No Action Indicated (NAI) | 2019-06-21 | 0 | 0 | null | false | -1 | packaging | compromised glove integrity |
Z-3030-2017 | device | CareFusion 303, Inc. | VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein. | Punctures in blister packaging that was detected during the packaging process. | Terminated | null | 2017-06-30 | 2017-08-23 | null | 1,546,800 units | null | 1034172 | 2 | 0 | No Action Indicated (NAI) | 2016-07-19 | 0 | 0 | null | false | 0 | packaging | punctured blister pack |
D-390-2014 | drug | Physicians Total Care, Inc. | Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked and Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 count bottle: NDC: 54868-0816-8, 60 count bottle: NDC: 54868-0816-4, 30 count bottle: NDC: 54686-0816-3. | Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing. | Terminated | null | 2013-11-22 | 2014-01-01 | CA, GA, NC, and MO | 3,000 tablets | null | 1641527 | 3 | 1 | No Action Indicated (NAI) | 2014-03-18 | 2 | 2 | 2013-01-10 | false | -1 | foreign_material | heavy metals detected |
D-0619-2025 | drug | Amneal Pharmaceuticals, LLC | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1. | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Ongoing | null | 2025-08-18 | 2025-09-10 | Distributed Nationwide in the USA | 3,363 100-count bottles | 69238-1054 | 3004488497 | 8 | 0 | No Action Indicated (NAI) | 2024-02-08 | 0 | 0 | null | false | 0 | foreign_material | microorganism contamination |
Z-0221-2017 | device | Windstone Medical Packaging, Inc. | Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility. | Terminated | null | 2015-04-22 | 2016-10-26 | null | 230 kits | null | 1000125955 | 2 | 0 | No Action Indicated (NAI) | 2019-06-21 | 0 | 0 | null | false | -1 | device_malfunction | splits or holes |
Z-3016-2020 | device | Cardinal Health 200, LLC | KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus. | Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment. | Terminated | null | 2020-07-30 | 2020-10-07 | null | 9,150 kits | null | 3010535719 | 2 | 0 | No Action Indicated (NAI) | 2016-08-23 | 0 | 0 | null | false | 0 | packaging | incorrect quantity |
Z-0284-2021 | device | Philips North America, LLC | Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop star... | The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode. | Terminated | null | 2020-09-14 | 2020-11-04 | null | 8,942 | null | 1218950 | 6 | 4 | Official Action Indicated (OAI) | 2018-12-04 | 2 | 1 | 2017-10-31 | true | 0 | device_malfunction | paddle failure detection |
Z-1921-2012 | device | DePuy Orthopaedics, Inc. | LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems whic... | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction ... | Terminated | null | 2012-05-16 | 2012-07-11 | null | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots | null | 3005572635 | 1 | 0 | No Action Indicated (NAI) | 2009-01-12 | 0 | 0 | null | false | 0 | device_malfunction | metal-on-metal articulation |
D-1174-2015 | drug | Lincare, Inc. | Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Terminated | null | 2015-05-28 | 2015-07-08 | United States including: Arkansas | 1 Bag | null | 3007636455 | 1 | 0 | No Action Indicated (NAI) | 2012-04-24 | 0 | 0 | null | false | 0 | sterility | lack of sterility assurance |
Z-1265-2020 | device | Abbott Point Of Care Inc. | i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood. | Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020. | Terminated | null | 2020-01-14 | 2020-02-26 | null | 4,448,525 | null | 2245578 | 2 | 0 | No Action Indicated (NAI) | 2017-09-20 | 0 | 0 | null | false | 0 | device_malfunction | insufficient clinical evidence |
Z-0512-2018 | device | Philips Medical Systems (Cleveland) Inc | BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as c... | During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor. | Terminated | null | 2017-12-15 | 2018-02-14 | null | 1387 in total | null | 1525965 | 10 | 2 | No Action Indicated (NAI) | 2019-11-26 | 1 | 1 | 2011-06-07 | false | -1 | device_malfunction | collimator alignment failure |
Z-0099-2026 | device | Boston Scientific Corporation | Model Number S702, ALTRUA 2 DR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life ... | Ongoing | null | 2025-08-20 | 2025-10-22 | null | 4055 units | null | 1000120754 | 3 | 0 | Voluntary Action Indicated (VAI) | 2014-10-09 | 0 | 0 | null | false | 0 | software | safety mode initiation |
D-1201-2015 | drug | Lincare, Inc. | Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Terminated | null | 2015-05-28 | 2015-07-08 | United States including: Arkansas | 15 Bags | null | 3002649792 | 1 | 0 | No Action Indicated (NAI) | 2012-03-22 | 0 | 0 | null | false | 0 | sterility | sterility not assured |
Z-1654-2018 | device | Siemens Healthcare Diagnostics, Inc. | Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results. | Terminated | null | 2017-06-29 | 2018-05-16 | null | 10,056 | null | 1000660462 | 1 | 0 | No Action Indicated (NAI) | 2013-04-03 | 0 | 0 | null | false | 0 | mislabeling | assay interference undisclosed |
Z-1828-2015 | device | Terumo Cardiovascular Systems Corp | Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. | The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user. | Terminated | null | 2015-05-06 | 2015-07-01 | null | 163 devices | null | 1000149028 | 3 | 0 | Voluntary Action Indicated (VAI) | 2017-09-25 | 0 | 0 | null | false | -1 | device_malfunction | incorrect indication use |
Z-1495-2024 | device | ConvaTec, Inc | ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit. | The product does not meet sterility assurance level. | Ongoing | null | 2024-02-27 | 2024-04-17 | null | 63 market units | null | 3011987967 | 6 | 2 | No Action Indicated (NAI) | 2015-09-08 | 1 | 1 | 2013-05-24 | false | 0 | sterility | inadequate assurance level |
Z-1884-2015 | device | Covidien LLC | Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119368P | Catheters may not meet antimicrobial specification | Terminated | null | 2015-04-23 | 2015-07-08 | null | 72,363 US - 24,631 Internationally | null | 1221611 | 1 | 0 | No Action Indicated (NAI) | 2010-11-30 | 0 | 0 | null | false | 0 | potency | antimicrobial specification failure |
D-1256-2022 | drug | Nephron Sterile Compounding Center LLC | HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30 | Lack of Assurance of Sterility | Terminated | null | 2022-06-30 | 2022-07-27 | Nationwide in the USA | 12,900 syringes | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lack of assurance |
D-0355-2018 | drug | Sage Products Inc | Toothette Short Term Oral Swab System with Perox-A-Mint Solution. Contains: 20 Individually wrapped Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44mL bottle of Perox-A-Mint solution and One (1) 0.5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product C... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Terminated | null | 2017-08-22 | 2018-02-21 | Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand | 966 cases | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | cross contamination |
Z-1726-2025 | device | Baxter Healthcare Corporation | Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP. | A cybersecurity vulnerability was discovered through internal testing. | Ongoing | null | 2025-04-07 | 2025-05-21 | null | 4174 units | null | 2025695 | 3 | 1 | No Action Indicated (NAI) | 2017-03-03 | 1 | 1 | 2013-12-19 | false | 0 | software | cybersecurity vulnerability |
D-1391-2020 | drug | Fresenius Kabi USA, LLC | Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10 | Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial. | Terminated | null | 2020-07-13 | 2020-07-22 | Nationwide within the United States | 63,067 vials | 63323-972 | 3014732157 | 3 | 2 | Official Action Indicated (OAI) | 2025-08-08 | 1 | 1 | 2024-01-04 | false | -1 | mislabeling | excipient quantity error |
Z-2495-2018 | device | Cardinal Health 200, LLC | Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile. | The suction valve may not close properly which could cause continuous suction. | Terminated | null | 2018-06-11 | 2018-07-25 | null | A total of 63,020 valves were distributed. Specific product quantities were not provided. | null | 3034315018 | 1 | 0 | No Action Indicated (NAI) | 2025-09-18 | 0 | 0 | null | false | -1 | device_malfunction | valve closure failure |
Z-1288-2022 | device | Baxter Healthcare Corporation | #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED | Packaging error. | Ongoing | null | 2022-05-17 | 2022-07-06 | null | 99 units | null | 2649614 | 7 | 1 | Voluntary Action Indicated (VAI) | 2023-11-29 | 1 | 1 | 2014-07-17 | false | -1 | packaging | labeling error |
Z-2378-2023 | device | Covidien LP | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629 | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resul... | Ongoing | null | 2023-06-28 | 2023-08-23 | null | 655 units | null | 1282497 | 8 | 0 | Voluntary Action Indicated (VAI) | 2022-11-18 | 0 | 0 | null | false | 0 | device_malfunction | catheter lumen occlusion |
D-1321-2022 | drug | Mckesson Medical-Surgical Inc. Corporate Office | Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated | null | 2022-06-29 | 2022-08-17 | Nationwide in the USA. | 1 box | 0065-8150 | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | improper storage conditions |
D-1462-2015 | drug | The Compounding Pharmacy of America | Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Terminated | null | 2015-06-02 | 2015-09-23 | Nationwide | 262 mL total volume | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | GMP violations |
Z-0090-2026 | device | Boston Scientific Corporation | Model Number L221 PROPONENT DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life ... | Ongoing | null | 2025-08-20 | 2025-10-22 | null | 3592 units | null | 3001451463 | 6 | 0 | No Action Indicated (NAI) | 2016-04-08 | 0 | 0 | null | false | 0 | software | safety mode prevention |
Z-2487-2018 | device | Cardinal Health 200, LLC | Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile. | The suction valve may not close properly which could cause continuous suction. | Terminated | null | 2018-06-11 | 2018-07-25 | null | A total of 63,020 valves were distributed. Specific product quantities were not provided. | null | 2016452 | 3 | 0 | No Action Indicated (NAI) | 2021-12-21 | 0 | 0 | null | false | -1 | device_malfunction | valve closure failure |
Z-1392-2019 | device | Boston Scientific Corporation | AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vapo... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message. | Terminated | null | 2019-04-08 | 2019-05-29 | null | 27 (OUS) | null | 1000120754 | 3 | 0 | Voluntary Action Indicated (VAI) | 2014-10-09 | 0 | 0 | null | false | 0 | device_malfunction | cooling system degradation |
D-1222-2022 | drug | TMC Acquisition LLC dba Tailor Made Compounding | Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | Ongoing | null | 2022-03-07 | 2022-07-20 | Nationwide USA and Puerto Rico | 58 vials | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | sterility assurance failure |
Z-2388-2024 | device | B. Braun Medical, Inc. | Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363421 | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood. | Ongoing | null | 2024-06-17 | 2024-07-24 | null | 1325700 | null | 3014301563 | 1 | 0 | Voluntary Action Indicated (VAI) | 2018-12-27 | 0 | 0 | null | false | 0 | device_malfunction | backcheck valve failure |
D-1695-2019 | drug | RXQ Compounding LLC | PREDNISOLONE 1%, MOXIFLOXACIN 0.5% OPHTH SOL, 5ML per dropper bottle, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0109-05 | Lack of Assurance of Sterility | Terminated | null | 2019-06-19 | 2019-08-14 | Nationwide USA | N/A | null | 3011509553 | 2 | 2 | Official Action Indicated (OAI) | 2017-08-08 | 1 | 1 | 2016-05-19 | true | 0 | sterility | sterility assurance failure |
Z-0971-2018 | device | Baxter Healthcare Corporation | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids. | Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion. | Terminated | null | 2017-10-06 | 2018-03-21 | null | 173,375 | null | 2650090 | 9 | 1 | Voluntary Action Indicated (VAI) | 2025-03-26 | 1 | 1 | 2011-01-20 | false | -1 | device_malfunction | pump mechanism wear |
Z-1277-2025 | device | Smiths Medical ASD, Inc. | smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24 | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | Ongoing | null | 2025-02-13 | 2025-03-26 | null | 3 units | null | 1221261 | 3 | 0 | Voluntary Action Indicated (VAI) | 2013-12-10 | 0 | 0 | null | false | 0 | device_malfunction | port separation defect |
Z-1007-2017 | device | Medtronic Navigation, Inc. | AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton. | Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation¿ System with Touch N Go Pointer Probes for patient registration. | Terminated | null | 2016-12-12 | 2017-01-18 | null | 111 devices | null | 1000517638 | 11 | 1 | Voluntary Action Indicated (VAI) | 2024-02-09 | 1 | 1 | 2010-05-07 | false | -1 | device_malfunction | registration accuracy issue |
Z-0257-2022 | device | CooperSurgical, Inc. | LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case. | Ongoing | null | 2021-09-29 | 2021-11-24 | null | 1587 Units | null | 1216677 | 15 | 1 | Voluntary Action Indicated (VAI) | 2024-05-21 | 2 | 2 | 2021-02-12 | false | -1 | device_malfunction | coagulation function failure |
Z-1263-2023 | device | DePuy Orthopaedics, Inc. | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118 | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. | Ongoing | null | 2023-02-15 | 2023-03-29 | null | 7 units | null | 1219655 | 2 | 0 | No Action Indicated (NAI) | 2015-09-24 | 0 | 0 | null | false | 0 | device_malfunction | excessive irradiation dose |
Z-0786-2013 | device | Philips Medical Systems (Cleveland) Inc | Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruc... | The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU). | Terminated | null | 2012-09-18 | 2013-03-06 | null | 1,474 Units | null | 3018004899 | 1 | 0 | No Action Indicated (NAI) | 2025-01-16 | 0 | 0 | null | false | -1 | device_malfunction | phantom pin degradation |
Z-1014-2020 | device | Cardinal Health | ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. | Terminated | null | 2020-01-11 | 2020-02-12 | null | 7,659,634 total units | null | 1017768 | 3 | 0 | Voluntary Action Indicated (VAI) | 2016-05-12 | 0 | 0 | null | false | 0 | contamination | bioburden and particulates |
Z-2619-2018 | device | ICU Medical, Inc. | 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or veni... | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. | Terminated | null | 2017-07-31 | 2018-08-15 | null | 160,016 units total | null | 3013319212 | 8 | 2 | No Action Indicated (NAI) | 2024-09-09 | 2 | 2 | 2013-05-09 | false | -1 | mislabeling | DEHP content claim |
Z-1822-2017 | device | Philips Electronics North America Corporation | The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010; Allura Xper FD10/10 722011; Allura Xper F... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, ... | Terminated | null | 2017-03-22 | 2017-04-26 | null | 6992 (total distributed for all products) | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | cooling system leak |
Z-1140-2019 | device | Philips Medical Systems Nederlands | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive pro... | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures. | Terminated | null | 2019-02-19 | 2019-04-24 | null | 7209 total | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | footswitch pedal bending |
Z-2189-2021 | device | Heartware, Inc. | HeartWare HVAD Pump Implant Kit, REF 1104 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as c... | Ongoing | null | 2021-06-03 | 2021-08-18 | null | 943 units | null | 3010767211 | 2 | 1 | Voluntary Action Indicated (VAI) | 2017-07-21 | 0 | 0 | null | false | 0 | device_malfunction | pump failure risk |
Z-1013-2019 | device | Boston Scientific Corporation | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210 | The sterile barrier may contain packaging seal defects. | Terminated | null | 2018-12-26 | 2019-03-20 | null | 18 units | null | 1051710 | 1 | 0 | No Action Indicated (NAI) | 2012-02-29 | 0 | 0 | null | false | 0 | null | null |
D-0532-2023 | drug | Pfizer Inc. | MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02 | Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025. | Ongoing | null | 2023-03-08 | 2023-04-19 | Nationwide in the USA | 1,926 Bottles | 70255-010 | 2416101 | 5 | 1 | No Action Indicated (NAI) | 2022-07-22 | 2 | 2 | 2012-05-24 | false | 0 | mislabeling | incorrect expiration date |
Z-1925-2015 | device | Roche Diagnostics Operations, Inc. | HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma. | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administra... | Terminated | null | 2015-05-07 | 2015-07-08 | null | 6255 | null | 1823260 | 9 | 0 | No Action Indicated (NAI) | 2022-12-07 | 0 | 0 | null | false | -1 | software | assay interference |
Z-0690-2021 | device | Boston Scientific Corporation | Five IceRod" i-Thaw" Prostate Cryoablation Kit | Complaint trend regarding needle shaft gas leaks. | Completed | null | 2020-11-18 | 2020-12-30 | null | 178 units | null | 3010178326 | 1 | 0 | Voluntary Action Indicated (VAI) | 2014-03-20 | 0 | 0 | null | false | 0 | device_malfunction | needle shaft leaks |
Z-0549-2013 | device | Zimmer, Inc. | Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosi... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone f... | Terminated | null | 2012-11-14 | 2012-12-26 | null | 92 | null | 1000220733 | 10 | 4 | No Action Indicated (NAI) | 2022-07-27 | 0 | 0 | null | false | -1 | device_malfunction | tibial perforation risk |
Z-2632-2014 | device | Fresenius Medical Care Holdings, Inc. | BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements, aluminum and zinc determination. | Products were held at improper storage temperature | Terminated | null | 2014-06-23 | 2014-09-24 | null | 2 each | null | 3001451489 | 8 | 4 | Official Action Indicated (OAI) | 2024-10-16 | 3 | 3 | 2023-12-04 | false | -1 | stability | improper storage temperature |
Z-1016-2020 | device | Cardinal Health | AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. | Terminated | null | 2020-01-11 | 2020-02-12 | null | 7,659,634 total units | null | 3001451686 | 3 | 0 | No Action Indicated (NAI) | 2017-11-21 | 0 | 0 | null | false | 0 | contamination | bioburden and particulates |
D-1563-2012 | drug | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML 400 ML (7 DIFFERENT PRODUCTS) | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Terminated | null | 2012-05-21 | 2012-08-22 | Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies | 8 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | microorganism contamination |
D-0845-2022 | drug | Mylan Pharmaceuticals Inc | Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80 | Labeling: Missing label on the vial | Terminated | null | 2022-04-12 | 2022-05-04 | USA nationwide. | 89,665 vials | null | 1051627 | 1 | 0 | No Action Indicated (NAI) | 2014-04-16 | 0 | 0 | null | false | 0 | mislabeling | missing label |
Z-2451-2016 | device | Biomet 3i, LLC | Titanium Square Uniscrew Dental implants | Pouches may not have been sealed during packing. | Terminated | null | 2015-11-25 | 2016-08-24 | null | 1,648,273 devices (all products subject to this recall) | null | null | null | null | null | null | 0 | 0 | null | false | null | packaging | unsealed pouches |
Z-1164-2022 | device | Busse Hospital Disposables, Inc. | Pain Tray Catalog Number: 9883 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Terminated | null | 2022-02-22 | 2022-06-08 | null | 421 units | null | 2433012 | 6 | 0 | Voluntary Action Indicated (VAI) | 2018-04-13 | 0 | 0 | null | false | 0 | cGMP | validation inadequacy |
Z-1859-2013 | device | Siemens Medical Solutions USA, Inc | syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo¿ Dynamics is not intended to be used for reading mammogr... | Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the mod... | Terminated | null | 2013-06-10 | 2013-08-07 | null | 9 | null | 2240869 | 3 | 0 | Voluntary Action Indicated (VAI) | 2022-10-26 | 0 | 0 | null | false | -1 | software | data save failure |
Z-2696-2020 | device | Philips North America, LLC | IntelliVue MX800 patient monitor, model no. 865240 | Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on. | Terminated | null | 2020-06-30 | 2020-07-29 | null | 28 | null | 1218950 | 6 | 4 | Official Action Indicated (OAI) | 2018-12-04 | 2 | 1 | 2017-10-31 | true | 0 | device_malfunction | defective power supply |
Z-0530-2025 | device | Boston Scientific Corporation | AMS Artificial Urinary Sphincter Control Pump | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) | Ongoing | null | 2024-10-28 | 2024-12-04 | null | 16 units | null | 3003882783 | 1 | 0 | No Action Indicated (NAI) | 2018-08-30 | 0 | 0 | null | false | 0 | mislabeling | wrong device packaged |
Z-0318-2014 | device | Ortho-Clinical Diagnostics | VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 In... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. | Terminated | null | 2013-06-12 | 2013-11-27 | null | 101,976 units (39,909 units domestically & 62,067 units internationally) | null | 3007111389 | 5 | 0 | No Action Indicated (NAI) | 2018-02-01 | 0 | 0 | null | false | -1 | device_malfunction | slide dispense failure |
D-0407-2021 | drug | Cardinal Health Inc. | FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 106 BOXES | 27241-118 | 2000029340 | 2 | 0 | No Action Indicated (NAI) | 2021-11-03 | 0 | 0 | null | false | -1 | cGMP | temperature excursion |
Z-1136-2020 | device | Abbott Vascular | NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation o... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Terminated | null | 2020-01-29 | 2020-02-26 | null | Total 39687 NC TREK units (13891 US and 25796 OUS) | null | 3006169760 | 1 | 0 | No Action Indicated (NAI) | 2011-07-20 | 0 | 0 | null | false | 0 | device_malfunction | balloon deflation failure |
Z-1517-2024 | device | Boston Scientific Corporation | EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509191 | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, lea... | Ongoing | null | 2024-02-20 | 2024-04-17 | null | 13 units (Japan) | null | 2648729 | 5 | 0 | No Action Indicated (NAI) | 2021-07-21 | 0 | 0 | null | false | 0 | device_malfunction | blocked lumen connector |
Z-0876-2019 | device | Philips Medical Systems Nederlands | Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | Terminated | null | 2018-12-21 | 2019-03-06 | null | 11226 total | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | magnetic attraction hazard |
Z-1962-2014 | device | Siemens Medical Solutions USA, Inc. | ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. | There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system. | Terminated | null | 2014-06-03 | 2014-07-09 | null | 790 units | null | 1000514697 | 3 | 0 | No Action Indicated (NAI) | 2019-06-10 | 0 | 0 | null | false | -1 | software | measurement tool error |
Z-1834-2021 | device | DeRoyal Industries Inc | DeRoyal Angio Cath Removal Tray, REF 89-9936.02 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine | Terminated | null | 2021-05-14 | 2021-06-16 | null | 60 trays | null | 1043214 | 4 | 0 | No Action Indicated (NAI) | 2017-12-08 | 0 | 0 | null | false | 0 | mislabeling | wrong drug concentration |
Z-1804-2023 | device | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds. | Ongoing | null | 2023-05-10 | 2023-06-28 | null | 34350 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | reduced energy output |
Z-1280-2018 | device | Baxter Healthcare Corporation | Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more w... | Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentio... | Terminated | null | 2017-02-15 | 2018-04-11 | null | 3,440 units | null | 1025114 | 11 | 5 | Official Action Indicated (OAI) | 2024-02-09 | 0 | 0 | null | false | -1 | software | syringe pump parameter revert |
Z-1810-2018 | device | Tosoh Bioscience Inc | Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay. | The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. | Terminated | null | 2018-03-05 | 2018-05-23 | null | 1485 | null | 3005529799 | 6 | 2 | Voluntary Action Indicated (VAI) | 2019-10-11 | 2 | 2 | 2016-08-05 | false | -1 | software | inaccurate results |
Z-1773-2015 | device | Philips Medical Systems (Cleveland) Inc | Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes. | Terminated | null | 2015-03-06 | 2015-06-17 | null | 156 units | null | 1525965 | 10 | 2 | No Action Indicated (NAI) | 2019-11-26 | 1 | 1 | 2011-06-07 | false | -1 | device_malfunction | battery failure hazard |
Z-0847-2015 | device | Natus Medical Incorporated | Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy. | Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some... | Terminated | null | 2014-11-19 | 2014-12-31 | null | 1907 total (1413 in US and 494 international) | null | 2023988 | 3 | 0 | No Action Indicated (NAI) | 2016-04-29 | 0 | 0 | null | false | -1 | device_malfunction | excessive light intensity |
Z-0822-2025 | device | Boston Scientific Corporation | ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance. | Ongoing | null | 2024-12-12 | 2025-01-22 | null | 156,329 units (59,937 US, 96,792 OUS) in total | null | 3002095335 | 11 | 0 | No Action Indicated (NAI) | 2025-03-18 | 0 | 0 | null | false | -1 | device_malfunction | battery impedance defect |
Z-0229-2014 | device | Carestream Health Inc. | Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all ... | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. | Terminated | null | 2013-09-16 | 2013-11-20 | null | null | null | null | null | null | null | 0 | 0 | null | false | null | software | image loading failure |
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