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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

Clear
DateProductReasonClassFirm
May 17, 2016 AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuo... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventila... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ven... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanic... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuo... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilat... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mech... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator in... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) ... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 TCA Board, 16542A A continuous ventilator intended to mechanically control o... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator inten... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechan... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
Apr 3, 2015 CareFusion AVEA ventilator, all models. Product Usage: A continuous venti... A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occl... Class I Carefusion 211 Inc dba Carefusion
Sep 5, 2013 Product Name: AVEA¿ Ventilator. All Models. The affected devices are clear... CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher ... Class I Carefusion 211 Inc dba Carefusion

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.