Browse Device Recalls

1,023 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,023 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,023 FDA device recalls — Class III.

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Date	Product	Reason	Class	Firm
Jul 3, 2018	Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarb...	Vials labeled for the prescriptions contained incorrect lenses	Class III	Alden Optical
Jul 3, 2018	Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbo...	Vials labeled for the prescriptions contained incorrect lenses	Class III	Alden Optical
Jun 22, 2018	Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: ...	Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for u...	Class III	Clarity Diagnostics Llc
Jun 14, 2018	RT-5100 Refractor, a component of the Epic-5100 System.	The lens bonding was incomplete on the refractor.	Class III	Nidek Inc.
Jun 5, 2018	Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027...	Distribution of unapproved product labeling	Class III	Tosoh Bioscience Inc
Jun 4, 2018	EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofu...	Mislabeled product	Class III	Richard-Allan Scientific Company
May 24, 2018	Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Dr...	Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an...	Class III	Beckman Coulter Inc.
May 24, 2018	Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured b...	Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu...	Class III	Beckman Coulter Inc.
May 24, 2018	Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Soft...	Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an...	Class III	Beckman Coulter Inc.
May 24, 2018	Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckma...	Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an...	Class III	Beckman Coulter Inc.
May 24, 2018	Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10...	Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu...	Class III	Beckman Coulter Inc.
May 24, 2018	Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No....	Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an...	Class III	Beckman Coulter Inc.
May 24, 2018	Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4...	Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an...	Class III	Beckman Coulter Inc.
May 23, 2018	Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studi...	Through an investigation, it has been determined that vials of Collagen packaged within the Colla...	Class III	Helena Laboratories, Corp.
May 23, 2018	Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation st...	Through an investigation, it has been determined that vials of Collagen packaged within the Colla...	Class III	Helena Laboratories, Corp.
May 16, 2018	BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Mode...	The solenoid plunger tip length is too short resulting in insufficient engagement to the Univers...	Class III	Becton, Dickinson and Company, BD Biosciences
May 8, 2018	Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: ...	Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.	Class III	Human Design Medical Llc
Mar 12, 2018	Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10...	Incorrect calibrator level listed in qualitative calibration steps	Class III	Siemens Healthcare Diagnostics, Inc.
Mar 12, 2018	Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 104...	Incorrect calibrator level listed in qualitative calibration steps	Class III	Siemens Healthcare Diagnostics, Inc.
Mar 2, 2018	BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829	The package insert incorrectly lists the volume of the primer and probe diluent to use for the re...	Class III	Becton Dickinson & Co.
Mar 2, 2018	BD MAX DNA MMK Lab Use, catalog no. 442828	The package insert incorrectly lists the volume of the primer and probe diluent to use for the re...	Class III	Becton Dickinson & Co.
Feb 27, 2018	SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation a...	Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended...	Class III	Helena Laboratories, Corp.
Feb 21, 2018	56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable ...	The secondary packaging is labeled with an incorrect expiration date.	Class III	CooperVision Inc.
Feb 21, 2018	clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, da...	The secondary packaging is labeled with an incorrect expiration date.	Class III	CooperVision Inc.
Feb 21, 2018	clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily dispo...	The secondary packaging is labeled with an incorrect expiration date.	Class III	CooperVision Inc.
Feb 21, 2018	56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable ...	The secondary packaging is labeled with an incorrect expiration date.	Class III	CooperVision Inc.
Feb 16, 2018	Strauss Penis Clamp 130MM/General Instruments	The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocess...	Class III	Aesculap Implant Systems LLC
Feb 16, 2018	Doyen-Collin Mouth Gag 120MM/ General Instruments	The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocess...	Class III	Aesculap Implant Systems LLC
Feb 13, 2018	Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Produ...	A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob wil...	Class III	Michigan Instruments, Inc.
Feb 7, 2018	HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for us...	Update XL¿ device software to version A.03. This includes enhancements to the Operational Check...	Class III	Philips Electronics North America Corporation
Jan 11, 2018	VITROS Immunodiagnostic Products TSH Reagent Pack	VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signa...	Class III	Clinical Diagnostic Systems
Jan 9, 2018	RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Us...	Product is labeled with "CE", but is not yet approved in the European Union.	Class III	Riverpoint Medical, LLC
Jan 5, 2018	Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic ...	Contains a gel-like contaminant that may affect product performance.	Class III	Diamedix Corporation
Jan 5, 2018	Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use...	Contains a gel-like contaminant that may affect product performance.	Class III	Diamedix Corporation
Dec 21, 2017	Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetri...	The kits contained an incorrect lot of Dropper Plus Level 1 vials	Class III	Quantimetrix Corporation
Dec 20, 2017	Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (01006083370...	The controls and calibrators contained within the cocaine test kit may cause false positive resul...	Class III	OraSure Technologies, Inc.
Dec 19, 2017	PerkinElmer 226 Sample Collection Device	PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the p...	Class III	PerkinElmer Health Sciences, Inc.
Dec 19, 2017	Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, S...	The product is labeled with the incorrect expiration date.	Class III	LivaNova USA
Dec 15, 2017	Alere iScreen Dx Urine Drug Screen Card	The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Anti...	Class III	Ameditech Inc
Dec 1, 2017	Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usa...	The firm made multiple changes to the product requiring the submission of a new 510(k) premarket ...	Class III	Mindray DS USA, Inc. dba Mindray North America
Nov 28, 2017	lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/...	The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce value...	Class III	Alere San Diego Inc. DBA Immunalysis Corporation
Nov 22, 2017	ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905...	The incorrect IFU was shipped with the product.	Class III	ECOLAB INC
Nov 22, 2017	ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906,...	The incorrect IFU was shipped with the product.	Class III	ECOLAB INC
Nov 7, 2017	T/Pump temperature therapy pump, Models TP700 and TP700C	The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence,...	Class III	Stryker Medical Division of Stryker Corporation
Nov 6, 2017	UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro...	Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w...	Class III	Beckman Coulter Inc.
Nov 6, 2017	Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vit...	Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w...	Class III	Beckman Coulter Inc.
Nov 6, 2017	Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic de...	Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w...	Class III	Beckman Coulter Inc.
Oct 29, 2017	OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use...	It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the f...	Class III	Xintec Corp
Oct 16, 2017	STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Numbe...	A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in th...	Class III	Keystone Dental Inc
Oct 3, 2017	Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Num...	Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue ...	Class III	Degania Silicone, Ltd.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.