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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.

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DateProductReasonClassFirm
Apr 20, 2015 Pediatric 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 Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used d... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Glaucoma 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 General 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 Emotion 6; the intended use of computed tomography is to produce cros... 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 Suction 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 113" (287cm) 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 Blepharoplasty 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 Head & 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 Surgical Pack and General Surgery Pack - contains Devon Light Glove Used du... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Skin and Vein 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 Vasc Custom Kit - 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 Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glo... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotati... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 Shoulder 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 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during sur... Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... Class II Stradis Healthcare, LLC.
Apr 20, 2015 Arthroscopy 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 Mississippi 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 Lima 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 19, 2015 Tibial Alignment Guide; Orthopedic Stereotaxic Instrument; Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignmen... Class II Zimmer CAS
Apr 17, 2015 WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping... The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 ... Class II Biosense Webster, Inc.
Apr 17, 2015 GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthope... Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws inst... Class II Medacta Usa
Apr 17, 2015 DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Produ... The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use. Class II DeRoyal Industries Inc
Apr 17, 2015 MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) The operator console allows users to deliver therapeutic radiation to patients even though a spec... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Apr 17, 2015 Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 O... Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was a... Class II Spacelabs Healthcare Inc
Apr 16, 2015 Hitachi Echelon Oval MRI System Image data transferred from the MRI system to a workstation showed errors on the slice position r... Class II Hitachi Medical Systems America 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 Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage... BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of... Class II BioHorizons Implant Systems Inc
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 MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 16, 2015 Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; T... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
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 PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONT... The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class II Wright Medical Technology, Inc.
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 Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM M... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
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 PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CO... The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class II Wright Medical Technology, Inc.
Apr 16, 2015 Hitachi Oasis MRI System Image data transferred from the MRI system to a workstation showed errors on the slice position r... Class II Hitachi Medical Systems America Inc
Apr 16, 2015 Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
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 Hitachi Echelon MRI System Image data transferred from the MRI system to a workstation showed errors on the slice position r... Class II Hitachi Medical Systems America Inc
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

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.