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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.