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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
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only.... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter C... Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro... Class II Teleflex Medical
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Sin... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use On... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are med... The exam light may have a tolerance issue with the adapter assembly, which could potentially not ... Class II Stryker Communications
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For S... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single U... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymat... May result in elevated platelet backgrounds during routine startup/background checks. Class II JAS Diagnostics Inc.
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Sin... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N293), REF 415369, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N211), REF 413043, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N350), IVD, REF 421037, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P629), REF 414576, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N292), REF 415063, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N217), REF 413080, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-GP71), REF 410750, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P621), REF 412533, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal f... Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Im... Class I EBI Patient Care, Inc.
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P644), IVD, REF 418673, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N285), REF 414740, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N315), IVD, REF 417426, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-GN82), REF 413439, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N363), IVD, REF 421692, 20 c... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N286), REF 414778, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N354), IVD, REF 421350, 20 c... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N272), REF 414164, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N324), IVD, REF 418603, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Streptococcus Susceptibility card (AST-ST03), IVD, REF 421040, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P640), IVD, REF 418579, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N352), IVD, REF 421258, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N320), IVD, REF 418204, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N233), REF 413117, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-GN87), REF 413943, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N209), REF 412938, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-GN81), REF 413438, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N204), REF 412865, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N238), REF 413203, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N208), IVD, REF 413062, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-GN75), REF 413432, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc

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.