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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

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Apr 22, 2015 Student Pack-NS, Kit number PSS2788 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 Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. ... 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 Transvaginal Pack, Kit number CMP1767 convenience custom kits used for gen... 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 Laparotomy Kit, Kit number PSS1036(A and PSS1036(B 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 Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenie... 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 Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS18... 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 Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for gen... 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 Major Kit, Kit number PHC1307(A convenience custom kits used for general sur... 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 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 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 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 21, 2015 Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer... Devices were placed in a shipper carton without the appropriate number of the Instructions for Us... Class III Zimmer Surgical Inc
Apr 9, 2015 Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/5... Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box an... Class II Coloplast Manufacturing US, 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
Mar 13, 2015 CareFusion Vital Signs LightWand Stylet. A device inserted into an endotra... Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3... Class II Vital Signs Colorado Inc.
Mar 13, 2015 Introduction Pack. A device inserted into an endotracheal tube to aid in the... Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3... Class II Vital Signs Colorado Inc.
Mar 10, 2015 LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QT... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, R... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK -... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO I... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX ... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm ... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE,... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, ... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MO... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Ste... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERIL... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 9, 2015 NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's D... A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC PMC RP 4.3x10mm, Article No. 37291. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc

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.