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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

172 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 172 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 172 FDA device recalls.

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DateProductReasonClassFirm
Nov 12, 2015 Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end... CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during... Class II CareFusion 303, Inc.
Nov 5, 2015 Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administe... CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection a... Class II CareFusion 303, Inc.
Oct 9, 2015 SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medic... CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues. Class II CareFusion 303, Inc.
Jul 21, 2015 Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affect... Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syring... Class I CareFusion 303, Inc.
May 13, 2015 Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Us... An issue with the cancel functionality used during atypical infusion programming to cancel user i... Class II CareFusion 303, Inc.
Mar 12, 2015 Alaris PC units, Model No. 8015. Infusion pump. CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur up... Class II CareFusion 303, Inc.
Jan 13, 2015 SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusio... CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage i... Class II CareFusion 303, Inc.
Jun 17, 2014 SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 1006... CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a... Class II CareFusion 303, Inc.
Apr 23, 2014 Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits... CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software ... Class I CareFusion 303, Inc.
Mar 19, 2014 SmartSite Extension Set, Model No. 20029E, intravascular administration set. Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port. Class II CareFusion 303, Inc.
Jan 22, 2014 SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless ... CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connec... Class II CareFusion 303, Inc.
Jan 16, 2014 Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, mod... CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they m... Class II CareFusion 303, Inc.
Dec 5, 2013 Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto... CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will... Class I CareFusion 303, Inc.
Nov 8, 2013 SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 243... CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer becau... Class II CareFusion 303, Inc.
Nov 8, 2013 VersaSafe Extension Set, Model No. 21000M-007 CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may ... Class II CareFusion 303, Inc.
Aug 30, 2013 CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are us... CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date.... Class II CareFusion 303, Inc.
Aug 30, 2013 SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing... CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 1301631... Class II CareFusion 303, Inc.
Aug 30, 2013 SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administr... CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is... Class II CareFusion 303, Inc.
Jun 17, 2013 Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic bo... CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is ope... Class I CareFusion 303, Inc.
Jun 29, 2012 Alaris Pump Module model 8100. Subsequent product code: FPA The Pump mo... The recall was initiated because Carefusion identified a potential risk associated with the Alari... Class I CareFusion 303, Inc.
Jun 15, 2012 Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Pro... The recall was initiated because Carefusion has identified a potential risk associated with the A... Class I CareFusion 303, Inc.
May 25, 2012 Alaris PC unit model 8015 Product Usage: The device is labeled for prescr... The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit pow... Class I CareFusion 303, 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.