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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Oct 20, 2017 HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx O... The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ... Class II Terumo BCT, Inc.
Oct 20, 2017 HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice... The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ... Class II Terumo BCT, Inc.
Oct 20, 2017 HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO... Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a sea... Class II Terumo BCT, Inc.
Nov 3, 2016 Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347. Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System b... Class II Terumo BCT, 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.