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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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Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

Clear
DateProductReasonClassFirm
Jun 23, 2017 POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: ... Inadequate detectability of radiopaque stripes Class II Kentec Medical Inc
Jun 23, 2017 Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The produ... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 18 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/case The products... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 3 CC L/S, 100 per box, 30 boxes/case, 3,000/case The produ... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 23 G X 1.0, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The product... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40... Inadequate detectability of radiopaque stripes Class II Kentec Medical Inc
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 b... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.0, 100 per box, 10 b... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 b... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 100 per box, 10 b... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The produ... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 27 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 22 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.5, 100 per box, 10 b... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 5/8, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,0... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 20 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case,... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The prod... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The produ... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 b... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 100 per box, 30 box... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluid... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The prod... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 22, 2017 AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAK... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LG... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom SPINE convenience kits, Item Code: LITT016-04 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LG... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 DLP Extension Line Adapters 20 in length Used to extend cardioplegia line du... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LG... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 The GC80 Digital X-ray Imaging System An image was obtained with over exposure during a Thorax examination using the AEC function. Class II NeuroLogica Corporation
Jun 22, 2017 AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure m... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia altern... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems

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.