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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

463 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 463 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 463 FDA device recalls.

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DateProductReasonClassFirm
Oct 8, 2012 Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method ... Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON... Class II Siemens Healthcare Diagnostics, Inc.
Aug 9, 2012 Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridg... Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibratio... Class II Siemens Healthcare Diagnostics, Inc.
Aug 3, 2012 Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is ... Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent ... Class III Siemens Healthcare Diagnostics, Inc.
Jul 30, 2012 Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital... Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. ... Class II Siemens Healthcare Diagnostics, Inc.
Jul 17, 2012 Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K408... Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) r... Class III Siemens Healthcare Diagnostics, Inc.
Jul 17, 2012 Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Hea... Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dime... Class II Siemens Healthcare Diagnostics, Inc.
Jun 7, 2012 EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informa... There is a potential for the EasyLink system to display and transmit to the Laboratory Informatio... Class II Siemens Healthcare Diagnostics, Inc.
Jun 7, 2012 Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classi... The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation anal... Class II Siemens Healthcare Diagnostics, Inc.
Jun 7, 2012 Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502... Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058... Class III Siemens Healthcare Diagnostics, Inc.
May 29, 2012 syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. ... When using the syngo Quality Control package the system may not perform as intended for Multi-Rul... Class II Siemens Healthcare Diagnostics, Inc.
May 29, 2012 EasyLink Informatic System is included with the Dimension Vista System. The ... When using the EasyLink Quality Control Package the system may not perform as intended for Multi-... Class II Siemens Healthcare Diagnostics, Inc.
May 8, 2012 Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B1... Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antib... Class II Siemens Healthcare Diagnostics, Inc.
Dec 1, 2010 BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usag... Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithr... Class II Siemens Healthcare Diagnostics, 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.