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Browse Device Recalls

164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 164 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 164 FDA device recalls.

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DateProductReasonClassFirm
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.