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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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Clear
DateProductReasonClassFirm
Aug 6, 2014 ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems... The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin... Class II Siemens Healthcare Diagnostics
Aug 6, 2014 MobileDiagnost wDR motorized portable diagnostic X-ray systems. Reports of unexpected movement. Class II Sedecal S.A.
Aug 6, 2014 Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Patter... AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... Class II Angiodynamics, Inc.
Aug 5, 2014 CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL... The firm became aware of a potential problem that was initiated by a customer complaint. After c... Class II Curbell Medical, Inc.
Aug 5, 2014 CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes a... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefil... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefill... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, ... Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves... Class II Catheter Connections, Inc.
Aug 4, 2014 Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is i... The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM. Class II Medical Components, Inc dba MedComp
Aug 3, 2014 Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). ... suction canister lids may have occluded ports. Class II EMG Technology Co., Ltd.
Aug 1, 2014 ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240... On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection... Class II Sorin Group USA, Inc.
Aug 1, 2014 CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STO... A pinhole leak identified in the packaging of the recalled product potentially could compromise t... Class II Civco Medical Instruments Inc
Jul 31, 2014 CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respira... The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory comp... Class II Carefusion 2200 Inc
Jul 31, 2014 Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 ... Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor be... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 31, 2014 Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: Th... It was discovered that a software defect may result in the scanner not terminating the CT scan a... Class II Philips Medical Systems, Inc.
Jul 31, 2014 Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 45356044604... Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 ... Class II Philips Electronics North America Corporation
Jul 31, 2014 Roche cobas IT 1000 Product Usage: Intended Use: An electronic device int... Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives ... Class II Roche Diagnostics Operations, Inc.
Jul 30, 2014 Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical... Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position. Class II Zimmer, Inc.
Jul 30, 2014 CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONL... Plates manufactured from an incorrect raw material. Class II Wright Medical Technology, Inc.
Jul 30, 2014 Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Tro... Internal review found that five (5) PFJ implant forgings were identified as have forged laps duri... Class II Zimmer, Inc.
Jul 30, 2014 CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EAC... Plates manufactured from an incorrect raw material. Class II Wright Medical Technology, Inc.
Jul 30, 2014 CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EAC... Plates manufactured from an incorrect raw material. Class II Wright Medical Technology, Inc.
Jul 30, 2014 Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container ... Integra LifeSciences has identified through an internal investigation that some colored lids for ... Class II Integra York PA, Inc
Jul 30, 2014 CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLA... Plates manufactured from an incorrect raw material. Class II Wright Medical Technology, Inc.
Jul 30, 2014 CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONL... Plates manufactured from an incorrect raw material. Class II Wright Medical Technology, Inc.
Jul 30, 2014 CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EAC... Plates manufactured from an incorrect raw material. Class II Wright Medical Technology, Inc.
Jul 30, 2014 CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONL... Plates manufactured from an incorrect raw material. Class II Wright Medical Technology, Inc.
Jul 30, 2014 CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONL... Plates manufactured from an incorrect raw material. Class II Wright Medical Technology, Inc.
Jul 30, 2014 CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY... Plates manufactured from an incorrect raw material. Class II Wright Medical Technology, Inc.
Jul 29, 2014 Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as p... The Directions for Use (DFU) manual contains information for devices that are not approved in the... Class II St. Jude Medical, Inc.
Jul 29, 2014 Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as p... The Directions for Use (DFU) manual contains information for devices that are not approved in the... Class II St. Jude Medical, Inc.
Jul 28, 2014 The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. Th... Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected... Class II Siemens Medical Solutions USA, Inc.
Jul 28, 2014 The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrat... Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected... Class II Siemens Medical Solutions USA, Inc.
Jul 28, 2014 RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data process... Class II Radiometer America Inc
Jul 28, 2014 Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina M... A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.... Class II Illumina Inc
Jul 28, 2014 Minstrel (with scale) Product Usage: is a mobile passive hoist. It is inte... ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. The... Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Jul 28, 2014 BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar... These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus ... Class II Becton Dickinson & Co.
Jul 27, 2014 IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and Intelli... The following software issues have been identified in the affected products. Problem 1: When reo... Class II Philips Medical Systems (Cleveland) Inc
Jul 25, 2014 Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (... Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its ca... Class II Estill Medical Technologies, Inc
Jul 25, 2014 SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for t... The integrity of the wires inside main electrical chord become compromised from excessive flexing... Class II JK Products & Services, Inc
Jul 25, 2014 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe ... Unit packages may exhibit open seals which impacts package integrity and potentially product ster... Class II Centurion Medical Products Corporation
Jul 25, 2014 GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-S... The adhesive used in the product could dislodge when objects are inserted through the valve which... Class II Galt Medical Corporation
Jul 25, 2014 GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate dig... GE Healthcare has become aware of a potential safety issue involving the nylon hooks which suppor... Class II GE Healthcare, LLC
Jul 25, 2014 GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO ... The adhesive used in the product could dislodge when objects are inserted through the valve which... Class II Galt Medical Corporation
Jul 25, 2014 ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9... Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. Class II OrthoPediatrics Corp
Jul 24, 2014 Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-... Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a differ... Class II Stryker Howmedica Osteonics Corp.
Jul 24, 2014 Philips IntelliSpace PACS 4.4 image management systems performs digital image... A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information... Class II Philips Healthcare Informatics, Inc.
Jul 23, 2014 VER2 D8L OFFSET RASP HANDLE, RT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left) The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 VER2 HANDLE, PIN REWORK, LT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, 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.