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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

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
Apr 22, 2015 Set Up Pack, Kit number PSS3574(A convenience custom kits used for general... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit co... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Minor Lap Pack, Kit number AMS2624 convenience custom kits used for genera... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Foot Pack, Kit number AMS3637 convenience custom kits used for general surge... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit co... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custo... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for gener... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience cus... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 16, 2015 Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog N... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711 Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog ... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/D... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/D... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA222... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:D... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Nu... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog N... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numb... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUB... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, si... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog ... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Apr 16, 2015 ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Nu... Devon Light Gloves contain splits or holes compromising the sterility Class II Covidien LLC
Mar 26, 2015 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Troc... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main c... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tr... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Tro... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 23, 2015 Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx ... Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Periphe... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Feb 26, 2015 CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telesco... Leaks were detected in the recalled lot which may compromise the sterility of the product. Class II Civco Medical Instruments Inc
Feb 16, 2015 Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000)... There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have... Class II Intuitive Surgical, Inc.
Feb 13, 2015 - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio ... The firm is recalling sterile enteral feeding syringes due to determining that the sterility of t... Class II Medela Inc. EF Division
Feb 5, 2015 Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, ... The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... Class II Zipline Medical
Feb 5, 2015 Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product numbe... The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... Class II Zipline Medical
Feb 5, 2015 Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product numb... The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... Class II Zipline Medical
Jan 9, 2015 NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 6010... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog N... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, 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.