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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

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

Clear
DateProductReasonClassFirm
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 21, 2015 EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut... Device does not mate as intended. Class II DePuy Spine, Inc.
Apr 21, 2015 PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT... At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was... Class II Hitachi America, Ltd., Power Systems Division
Apr 21, 2015 Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 01... Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with... Class II Spacelabs Healthcare Inc
Apr 20, 2015 Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is a... Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed ... Class II Siemens Healthcare Diagnostics, Inc.
Apr 20, 2015 Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Eye Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Neurosurgery Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Bariatric Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Set Up Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inh... Roscoe Medical has recently identified the need to update its user manual with additional warning... Class II Compass Health Brands
Apr 20, 2015 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 Gyn Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Dev... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Stradi 4500 - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Face Lift Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 ACL Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used dur... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Basic Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Breast Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during s... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Tummy Tuck Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 DND Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Advanced Vein Care - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Open Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Upper Extremity Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Cysto Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Face Neck Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext S... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 Podiatry Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 Face Lift Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 SOMATOM Perspective; the intended use of computed tomography is to produce cr... Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... Class II Siemens Medical Solutions USA, Inc
Apr 20, 2015 Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pac... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 SOMATOM Emotion 16, the intended use of computed tomography is to produce cro... Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... Class II Siemens Medical Solutions USA, Inc
Apr 20, 2015 Hand Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during s... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 ENT Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Hand Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Vein & Vascular Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 Standard Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore T... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon L... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Custom Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, 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.