CryoLife, Inc.

Complete recall history across all FDA and CPSC categories — 14 total recalls

CryoLife, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (14)

FDA medical device enforcement actions by CryoLife, Inc.

Date Product Reason Class
Oct 7, 2021 BioGlue Surgical Adhesive, Model BG3510-5-G Product is not approved for use in the EU and should not have been distribute... Class II
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 micro... Class II
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 micro... Class II
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
Sep 6, 2018 CryoPatch SG Pulmonary Hemi-Artery, 1 graft The conduit length and branch length of a SG Pulmonary Hemi-Artery were switc... Class II
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" ... Class II
May 14, 2018 Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 Devices, which met FDA and AATB eligibility criteria, were distributed. Fina... Class II
May 14, 2018 Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO Devices, which met FDA and AATB eligibility criteria, were distributed. Fina... Class II
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 17M... Class II
Nov 21, 2016 CryoPatch SG Pulmonary Hemi-Artery Patch The device is recalled due to donor ineligibility of released human tissue. T... Class II
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 S... Class II
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 ... Class II
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 redistribu... Class II
Nov 22, 2013 Pulmonary Hemi-Artery SG Used in heart surgery Serological testing for the donor was performed with a blood sample that may ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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