Browse Device Recalls

690 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 690 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 690 FDA device recalls.

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DateProductReasonClassFirm
Apr 26, 2018 SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA univer... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Ite... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLE... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA uni... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BO... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The End... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX VMIN ZESTAW DO VATS PODSTAWOWY Product Usage: The Endo GIA universal... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX VATS1SCDX DO ZABIEGOW VATS Product Usage: The Endo GIA universal and... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and En... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) Product Usage: The Endo GIA ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal an... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and E... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA uni... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HE... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 26, 2018 BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA univer... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
Apr 9, 2018 EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, P... There is a potential for improper welding of the yellow staple guide to the instrument. Use of a ... Class II Covidien LLC
Apr 9, 2018 EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, P... There is a potential for improper welding of the yellow staple guide to the instrument. Use of a ... Class II Covidien LLC
Mar 15, 2018 LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipola... Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged de... Class II Covidien LLC
Dec 19, 2017 DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray wit... DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tr... Class II DeRoyal Industries Inc
Dec 13, 2017 Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia... Product reportedly shutting down during use. Class II Covidien LLC
Nov 21, 2017 Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilato... Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Benne... Class II Covidien LLC
Oct 12, 2017 Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Si... This voluntary recall is being conducted due to the potential for failure to detect the affected... Class II Covidien LLC
Sep 21, 2017 GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastr... Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastri... Class II Covidien LLC
Sep 15, 2017 Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial r... The device cartridge disengaged during use due to manufacturing error. Class II Covidien LLC
Sep 13, 2017 Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal... Potential for failure of the device safety interlock. The safety interlock prevents an empty sing... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (rei... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Mat... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Mat... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (rei... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (rei... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Mat... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Jul 17, 2017 Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon... Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable s... Class II Covidien LP
May 9, 2017 Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The ... Cotton tip of the device may disengage due to insufficient adhesive Class II Covidien LLC
Mar 16, 2017 Ortho Basic Pack, part number AMS6459 Product packaged in a convenient ma... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a conven... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a con... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Minor Operation Kit, part number AMS1530 Product packaged in a convenient ma... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.

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.