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Browse Device Recalls

24 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 24 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 24 FDA device recalls.

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DateProductReasonClassFirm
Nov 27, 2018 Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal T... Potential for pouch seal failure Class II AROA BIOSURGERY
Nov 27, 2018 Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal T... Potential for pouch seal failure Class II AROA BIOSURGERY
Nov 27, 2018 Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal T... Potential for pouch seal failure Class II AROA BIOSURGERY
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was... Class II AROA Biosurgery, LTD.

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.