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Vehicle Safety

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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

1,516 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,516 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 1,516 FDA device recalls in FL.

Clear
DateProductReasonClassFirm
Jul 18, 2016 BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for t... The adhesive may be inadequately applied or the assembly may be manipulated after application of ... Class II Bovie Medical Corporation
Jun 29, 2016 TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intende... Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati... Class II Winco Mfg., LLC
Jun 29, 2016 TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended u... Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati... Class II Winco Mfg., LLC
Jun 29, 2016 TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Ch... Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati... Class II Winco Mfg., LLC
Jun 28, 2016 TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult... Product gives incorrect low blood glucose levels. Class II Trividia Health
Jun 28, 2016 NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, St... Wire in tubing can become exposed, posing potential harm to the intubated patient. Class II Medtronic Xomed, Inc.
Jun 28, 2016 TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult... Product gives incorrect low blood glucose levels. Class II Trividia Health
Jun 28, 2016 TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult... Product gives incorrect low blood glucose levels. Class II Trividia Health
Jun 28, 2016 TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult... Product gives incorrect low blood glucose levels. Class II Trividia Health
Jun 24, 2016 Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage:... There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery... Class I The Anspach Effort, Inc.
Jun 24, 2016 Light Adaptor for Small Battery Drive and Small Battery Drive II. There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery... Class I The Anspach Effort, Inc.
Jun 21, 2016 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating... Elevating Monitor Suspension separated from the lifting column bracket Class II Omega Medical Imaging, Inc.
Jun 15, 2016 Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting... The graphics at the attachment interface indicating locked and unlocked position are reversed. Class II The Anspach Effort, Inc.
Jun 13, 2016 Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure o... Potential sterility deficiency. Class II Biomet Microfixation, LLC
Jun 8, 2016 HeartWare Ventricular Assist System Controller Product Usage: For use as... Loose connector ports in controller body. Class I Heartware, Inc.
May 26, 2016 Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femor... Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the... Class II Exactech, Inc.
May 26, 2016 Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femor... Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the... Class II Exactech, Inc.
May 20, 2016 Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. Product did not meet specifications for Zinc Acetate (OOS). Class II Amerx Health Care Corp.
May 6, 2016 Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Chan... A diode was inadvertently not assembled into the system, which may result in coil overheating Class II Invivo Corporation
May 4, 2016 Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid) Inability to deploy the stent or partial stent deployment. Class II Cordis Corporation
May 4, 2016 Cordis PRECISE (R) RX Nitinol Stent System (Biliary) Inability to deploy the stent or partial stent deployment. Class II Cordis Corporation
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 21, 2016 The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile.... During an FDA inspection it was found that the products are marketed without a cleared 510k, nor ... Class II Miami Fat Supply, Inc
Apr 20, 2016 Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Out... The design of the seats did not consistently have the adequate strength required to support the c... Class II Acorn Stairlifts, Inc
Apr 15, 2016 Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and ... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetra... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment a... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garme... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment an... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garmen... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garm... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 12, 2016 Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11,... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabula... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral St... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, 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.