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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Mar 9, 2015 Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is use... Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Fa... Class II Bacterin International, Inc.
May 15, 2014 Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical... The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014)... Class II Bacterin International, Inc.
Feb 21, 2013 OsteoSelect DBM Putty Product Usage: Orthopedic bone filler The firm's retesting procedure was not validated. Class II Bacterin International, Inc.
Jan 28, 2013 Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hub... A portion of a silicone wound drain was found to be cracked. Class II Bacterin International, Inc.
Apr 18, 2012 Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty... Expired product was shipped to two customers. Class II Bacterin International, 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.