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Browse Device Recalls

75 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 75 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 75 FDA device recalls.

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DateProductReasonClassFirm
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)
May 6, 2013 Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST ... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code:... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONB... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Produ... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Produc... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product... Seals may disengage from the cannula which may result in a component inadvertently disengaging in... Class II Covidien LP
Feb 11, 2013 Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm ... Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in d... Class II 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 21, 2012 Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Prod... Duet TRS may have the potential to injure adjacent anatomical structures which may result in life... Class II Covidien LP
Aug 21, 2012 Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Prod... Duet TRS may have the potential to injure adjacent anatomical structures which may result in life... Class II Covidien LP
Aug 21, 2012 Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Produ... Duet TRS may have the potential to injure adjacent anatomical structures which may result in life... Class II Covidien LP
Aug 21, 2012 Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures which may result in life... Class II Covidien LP
Aug 21, 2012 Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures which may result in life... Class II Covidien LP
Aug 21, 2012 Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Prod... Duet TRS may have the potential to injure adjacent anatomical structures which may result in life... Class II Covidien LP
Aug 21, 2012 Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures which may result in life... Class II Covidien LP
Aug 21, 2012 Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures which may result in lif... Class II 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)
May 9, 2012 Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA T... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA T... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA ... Potential for the sterility barrier to be compromised. Class II 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.