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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

3,264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,264 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 3,264 FDA device recalls.

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DateProductReasonClassFirm
Oct 13, 2017 Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device insi... Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. Class II Ecolab, Inc.
Sep 13, 2017 Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF H... It was determined that the deflection length indicated on the Guide catheter handle does not matc... Class II Medtronic Vascular, Inc.
Sep 7, 2017 The 2nd Assist Knee Positioner Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to ... Class II Zimmer Biomet, Inc.
Jul 24, 2017 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jul 24, 2017 NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral ... There is a possibility that the protective foam insert used during the packaging of the affected ... Class II ZIMMER ORTHOPEDIC MFG LTD
Jul 24, 2017 Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jul 24, 2017 CVC Tray Pediatrics. Product Code: AMS-9335CP-2. Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jul 24, 2017 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jul 24, 2017 3-Way Standardbore Stopcock. Product Code: AMS-100. Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jul 17, 2017 Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon... Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable s... Class II Covidien LP
Jul 5, 2017 HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product... Baxter Healthcare Corporation has been made aware that users may not be following the instruction... Class II Baxter Healthcare Corporation
Jul 5, 2017 HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usa... Baxter Healthcare Corporation has been made aware that users may not be following the instruction... Class II Baxter Healthcare Corporation
Jun 30, 2017 DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty Product may contain the presence of melted sterile packaging upon opening. Class II Zimmer Biomet, Inc.
Jun 30, 2017 VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used... Punctures in blister packaging that was detected during the packaging process. Class II CareFusion 303, Inc.
Jun 26, 2017 Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
Jun 26, 2017 Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERIL... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
Jun 26, 2017 Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
Jun 26, 2017 Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERIL... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
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 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 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
Jun 22, 2017 DLP Pressure Disposable Pressure Display Sets Extends the pressure line in o... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 13, 2017 BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The B... Presence of loose polypropylene foreign matter above release specification. Class II Becton Dickinson & Company
Jun 7, 2017 Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDO... Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. Th... Class II Randox Laboratories Ltd.
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolp... Lack of sterility assurance. There is a defect in the primary packaging of the device, which may... Class II DeRoyal Industries Inc
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 5, 2017 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm lengt... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter ... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
May 25, 2017 Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part... Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received ... Class II Atrium Medical Corporation
May 22, 2017 TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE There is a potential risk of puncture to the packaging material which can compromise the devices ... Class II Somatex Medical Technologies GmbH

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.