Browse Device Recalls

675 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 675 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 675 FDA device recalls.

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DateProductReasonClassFirm
Apr 8, 2013 Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Produ... Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could re... Class II Covidien LLC
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)
Jan 7, 2013 Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecon... There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the... Class II Integra LifeSciences Corp.
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 3, 2012 HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) ... Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; an... Class II Covidien LLC
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
Feb 9, 2012 Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. ... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Ma... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, ... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO b... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch

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.