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 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. |
| Mar 16, 2017 | Cataract Kit, part numbers CAT1467AM and CAT1538(B. 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. |
| Mar 16, 2017 | Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a co... | 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 | ENT Pack, part number AMS2727 Product packaged in a convenient manner for us... | 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 | Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner fo... | 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 | Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in... | 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 | Setup Pack, part number AMS3112(A Product packaged in a convenient manner fo... | 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 | Vitrectomy Pack, part number AMS4952 Product packaged in a convenient mann... | 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 | Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a c... | 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 | Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient mann... | 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 | PRK Tray, part number DDS1044 Product packaged in a convenient manner for ... | 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 | Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient ... | 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 | Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, a... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 9, 2017 | OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individuall... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and st... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads ... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
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.