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Vehicle Safety

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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

2,055 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,055 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 2,055 FDA device recalls in N/A.

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DateProductReasonClassFirm
Mar 24, 2016 NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body comput... The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version... Class II Philips and Neusoft Medical Systems Co., Ltd.
Mar 14, 2016 Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structu... There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class II Ossur H / F
Mar 14, 2016 Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structu... There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class II Ossur H / F
Mar 14, 2016 Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structur... There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class II Ossur H / F
Mar 14, 2016 Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure... There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class II Ossur H / F
Mar 14, 2016 Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure u... There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class II Ossur H / F
Mar 14, 2016 Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure u... There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class II Ossur H / F
Mar 11, 2016 Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product U... The units have been fitted with a potentially faulty power supply cable. Class II RESEARCH INSTRUMENTS LTD - SITE B
Mar 7, 2016 VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Ac... In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the fi... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Feb 24, 2016 Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an ac... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used ... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Unloader Custom Product Usage: Unloader Custom is an external knee braces... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 NecLoc Extrication Collar Product Usage: Necloc collars are applied to pa... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Miami J Collar Product Usage: Miami J collars are applied to patients aff... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Extreme Custom Product Usage: Extreme Custom is an external knee braces t... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reo... Product does not meet sterility requirements based on FDA analysis and tested positive for Bacter... Class II Amd Ritmed
Feb 24, 2016 Unloader XT Product Usage: Unloader XT Extreme is an external knee braces... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an acc... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Rebound Cartilage Product Usage: Rebound Cartilage is an external knee br... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an ex... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose P... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Unloader Custom Lite Product Usage: Unloader Custom Lite is an external ... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 24, 2016 Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for g... Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio... Class II Ossur H / F
Feb 10, 2016 RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4... A software issue with editing tools that use the left mouse button held down, for drawing in and ... Class II RAYSEARCH LABORATORIES AB
Jan 29, 2016 PINPOINT Endoscopic Fluorescence Imaging System It has been determined that the PINPOINT Operator's Manual does not contain validated parameters ... Class II Novadaq Technologies Inc.
Jan 21, 2016 Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, ... Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 month... Class II Biomet France SARL
Jan 18, 2016 Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by ... This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x... Class II Sedecal S.A.
Jan 8, 2016 API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional tes... Discrepant identification results related to API identification strips. These discrepant identif... Class II BioMerieux SA
Jan 5, 2016 Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Inst... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Pro... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usag... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Produc... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Produ... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instrum... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford P... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Us... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Produc... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usag... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usag... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments f... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Pro... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Produ... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., 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.