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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
Oct 7, 2021 BioGlue Surgical Adhesive, Model BG3510-5-G Product is not approved for use in the EU and should not have been distributed in the EU. Class II CryoLife, Inc.
Nov 10, 2020 CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a ... On November 10, 2020, it was discovered that there are post- processing microbial culture test fa... Class II CryoLife, Inc.
Nov 10, 2020 CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a ti... On November 10, 2020, it was discovered that there are post- processing microbial culture test fa... Class II CryoLife, Inc.
Jan 17, 2019 On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X... On-X Valve was mislabeled with the incorrect serial number. Class II CryoLife, Inc.
Sep 6, 2018 CryoPatch SG Pulmonary Hemi-Artery, 1 graft The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product l... Class II CryoLife, Inc.
Jun 4, 2018 BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is i... The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorr... Class II CryoLife, Inc.
May 14, 2018 Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxico... Class II CryoLife, Inc.
May 14, 2018 Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxico... Class II CryoLife, Inc.
May 19, 2017 BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot... Class II CryoLife, Inc.
Nov 21, 2016 CryoPatch SG Pulmonary Hemi-Artery Patch The device is recalled due to donor ineligibility of released human tissue. The firm received inf... Class II CryoLife, Inc.
Jun 12, 2015 On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement ... Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring ... Class II CryoLife, Inc.
Apr 25, 2014 BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (Bio... Serum albumin component monomer failed to meet internally established end of shelf-life specifica... Class II CryoLife, Inc.
Feb 12, 2014 On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indi... Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 ... Class II CryoLife, Inc.
Nov 22, 2013 Pulmonary Hemi-Artery SG Used in heart surgery Serological testing for the donor was performed with a blood sample that may have been hemodilute... Class II CryoLife, 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.