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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

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DateProductReasonClassFirm
Mar 24, 2023 FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Mar 24, 2023 FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Mar 24, 2023 FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Mar 23, 2023 WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (s... The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclo... Class II ASO LLC
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS007... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR0... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and ... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU0... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 an... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 22, 2023 STA R Max fully automatic clinical instrument designed to perform tests on hu... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS0101... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 a... Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A... Class II Becton Dickinson & Co.
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C -... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... Class II Covidien LP
Mar 22, 2023 VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... Class II Covidien LP
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E -... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C -... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... Class II Covidien LP
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-202... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM I... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Numb... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item ... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Nu... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.... Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item N... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: ... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40 Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Num... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Num... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.

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.