Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BioGlue Spreader Tip Recalled by CryoLife, Inc. Due to The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CryoLife, Inc. directly.
Affected Products
BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).
Quantity: 855 Total
Why Was This Recalled?
The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
Where Was This Sold?
Distribution is to Japan
About CryoLife, Inc.
CryoLife, Inc. has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report