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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

Clear
DateProductReasonClassFirm
Oct 1, 2014 Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in ... A software issue may lead to ventilator inoperative situations. Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Oct 1, 2014 Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien ... Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter... Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jul 17, 2014 Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other ... Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jul 17, 2014 Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other elect... Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform a... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jun 4, 2014 Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a compone... In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator con... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jun 3, 2014 Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator Syst... Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventila... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Apr 18, 2014 Recalled product is a component of the Newport Medical Instruments e360 Vent... Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilat... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jan 25, 2013 Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066... Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor),... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jan 25, 2013 Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operato... Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor),... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Aug 1, 2012 DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kit... Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grou... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jul 18, 2012 Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers... Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related... Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)

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.