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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

806 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 806 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 806 FDA device recalls.

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DateProductReasonClassFirm
Aug 12, 2016 Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Jul 25, 2016 Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 25, 2016 Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 25, 2016 Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader fo... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 25, 2016 SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance read... The batteries have the potential to overheating, melt or char. Class II Tecan US, Inc.
Jul 15, 2016 Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOP... Quality control identified a component issue where the pinion gear in the device could fail under... Class II Ethicon Endo-Surgery Inc
Jul 15, 2016 Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH E... Quality control identified a component issue where the pinion gear in the device could fail under... Class II Ethicon Endo-Surgery Inc
Jun 30, 2016 Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 30, 2016 Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 10, 2016 Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vi... An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in thi... Class II Dako North America Inc.
May 6, 2016 Ariol is an automated scanning microscope and image analysis system. It is in... An issue during the manufacturing process caused systems to have an improperly activated Windows ... Class III Leica Biosystems Richmond Inc.
Mar 31, 2016 Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog... Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some ... Class III Biocare Medical, LLC
Mar 28, 2016 Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar C... Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with L... Class II Becton Dickinson & Co.
Mar 25, 2016 The Plum 360 is a large volume infuser capable of delivering fluids for a var... Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att... Class II Hospira Inc.
Feb 16, 2016 Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retrac... Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retract... Class II Biomet, Inc.
Feb 12, 2016 BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, ... BD has confirmed that a portion of BD SurePath" collection vials associated with specific product... Class II Becton Dickinson & Co.
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, ceme... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 8, 2016 Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localizati... Product potentially exposed to body fluids during processing. Potential adverse events that may ... Class II Cook Inc.
Dec 1, 2015 CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively... Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood... Class II Partners In Medicine Llc
Nov 20, 2015 IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Numbe... During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... Class II Boston Scientific Corp
Nov 20, 2015 IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Numbe... During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... Class II Boston Scientific Corp
Nov 20, 2015 IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: ... During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... Class II Boston Scientific Corp
Nov 20, 2015 IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M00... During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... Class II Boston Scientific Corp
Oct 23, 2015 GE Healthcare, Revolution CT Scanners. Revolution CT- The system is inte... GE Healthcare has recently become aware of a potential issue with routine head scans on your Revo... Class II GE Medical Systems, LLC
Oct 9, 2015 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... Class I Boston Scientific Corporation
Oct 9, 2015 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... Class I Boston Scientific Corporation
Oct 6, 2015 Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path Leakage from the inlet port of the 15L Cycler Drainage Bags. Class II Baxter Healthcare Corp.
Aug 5, 2015 The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departme... The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm ... Class III Leica Microsystems, Inc.
Jul 27, 2015 The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. ... The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty du... Class II Leica Microsystems, Inc.
Jul 20, 2015 Neptune 2 Waste Management System Docking Station (120V and 230V), New and Re... The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be ... Class II Stryker Instruments Div. of Stryker Corporation
Jul 10, 2015 Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel T... Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# ... Class II Stryker Sustainability Solutions
Jun 30, 2015 PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper b... A reagent present may produce weak or slow reactions; continued use may result in a failure to id... Class II Remel Inc
Jun 30, 2015 PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex ... A reagent present may produce weak or slow reactions; continued use may result in a failure to id... Class II Remel Inc
Jun 24, 2015 HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 ... Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. Class II Hardy Diagnostics
Jun 15, 2015 BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, B... Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to th... Class III BD Biosciences, Systems & Reagents
May 27, 2015 DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm... certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0... Class II Synthes, Inc.
May 22, 2015 0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (... Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to compla... Class II Stryker Instruments Div. of Stryker Corporation
May 13, 2015 Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientif... Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in t... Class II The Binding Site Group, Ltd.
May 4, 2015 Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID P... Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Se... Class II Smiths Medical Asd Inc
Mar 25, 2015 Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin wit... Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT ... Class II Siemens Healthcare Diagnostics, Inc.
Mar 17, 2015 CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage... A drop in staining intensity over time has been observed. These lots may not meet their labeled s... Class II Biocare Medical, LLC
Feb 26, 2015 ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Produ... During an internal inspection of the production process the firm discovered an issue which may ca... Class II Ethicon Endo-Surgery Inc
Feb 4, 2015 NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Siz... One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. Class II Zimmer Trabecular Metal Technology, Inc.
Jan 7, 2015 Cold Therapy Pad - cold water circulating pad, one unit per package. The pa... Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead t... Class II Cincinnati Sub-Zero Products Inc
Dec 16, 2014 Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunoh... The staining intensity decreases over the shelf life. Class II Leica Microsystems, Inc.
Dec 8, 2014 Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid ... Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Casse... Class II Baxter Healthcare Corp.

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.