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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

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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

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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DateProductReasonClassFirm
Apr 15, 2016 TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 005886... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, 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 Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for s... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook 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 14, 2016 Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: ... BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... Class II B. Braun Medical, Inc.
Apr 14, 2016 Syngo Dynamics; Kinetdx Picture Archiving and Communications System Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syng... Class II Siemens Medical Solutions USA, Inc
Apr 14, 2016 MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product U... A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System. Class II Toshiba American Medical Systems Inc
Apr 14, 2016 LenSx Laser System. Indicated for use in patients undergoing cataract surger... Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after rec... Class II Alcon Research, Ltd.
Apr 14, 2016 Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208,... Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in ... Class II Biosense Webster, Inc.
Apr 14, 2016 Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D12... Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in ... Class II Biosense Webster, Inc.
Apr 14, 2016 Magnesium on RX Imola analyser IVD According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run... Class II Randox Laboratories, Limited
Apr 14, 2016 HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the t... MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may hav... Class II Philips Electronics North America Corporation
Apr 14, 2016 CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, w... During a recent Ohio site inspection by the FDA it was discovered that warning statements needed ... Class III Affymetrix Inc
Apr 14, 2016 Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve ... BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... Class II B. Braun Medical, Inc.
Apr 13, 2016 Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is ... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, M... The docking station top cover of the removable patient table may contain a magnetic metal plate. ... Class II Siemens Medical Solutions USA, Inc
Apr 13, 2016 Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as ... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... Fetal patient report was automatically pulling prior measurement data for a prior fetus since the... Class II Merge Healthcare, Inc.
Apr 13, 2016 Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is inte... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor... Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used ... Class I Medtronic
Apr 13, 2016 Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended a... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 12, 2016 Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-03... Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem w... Class II Toshiba American Medical Systems Inc
Apr 12, 2016 CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orth... Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock F... Class II Stryker Corporation
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.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Ortho... Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock F... Class II Stryker Corporation
Apr 12, 2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, 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 14, Femoral St... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Distal Femoral Replacement (patient specific, custom made orthopedic implant ... Incorrect component used to manufacture distal femoral replacement. Class II Stanmore Implants Worldwide Ltd.
Apr 11, 2016 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteu... IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and ... Class II Ion Beam Applications S.A.
Apr 11, 2016 EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd... Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in... Class II Ethicon, Inc.
Apr 11, 2016 Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assemb... The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Photother... Class II Natus Medical Incorporated
Apr 11, 2016 PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to acces... The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay ... Class II Biomet, Inc.
Apr 11, 2016 TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25... Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient ... Class II Echopixel, Inc.
Apr 8, 2016 DR Systems Unity PACS software, now known as Merge Unity PACS Reports were missing demographic header information when they were faxed to referring physicians. Class II Merge Healthcare, Inc.
Apr 8, 2016 Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to pr... The firm became aware of a problem where the system may not map Varian drive after CT user logout... Class II Philips Medical Systems (Cleveland) Inc
Apr 8, 2016 ROSA Surgical Device 2.5.8 Potential for software to change the final tool orientation for the command position without comm... Class II Zimmer Biomet, Inc.
Apr 8, 2016 Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended t... The firm became aware of a problem where the system may not map Varian drive after CT user logout... Class II Philips Medical Systems (Cleveland) Inc
Apr 8, 2016 ACUSON SC2000 Ultrasound imaging system with software version VB10C and using... While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the abi... Class II Siemens Medical Solutions USA, Inc.
Apr 8, 2016 Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Inten... The firm became aware of a problem where the system may not map Varian drive after CT user logout... Class II Philips Medical Systems (Cleveland) Inc
Apr 8, 2016 Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Inten... The firm became aware of a problem where the system may not map Varian drive after CT user logout... Class II Philips Medical Systems (Cleveland) Inc
Apr 8, 2016 SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SM... Complaints of intra-operative breakage of the glenosphere impactors/extractors. Class II Limacorporate S.p.A
Apr 8, 2016 Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for u... Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecti... Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Apr 8, 2016 DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usa... The software is not adding the correct tomo image. Class II Merge Healthcare, 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.