Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BioGlue Surgical Adhesive Recalled by CryoLife, Inc. Due to The courtesy labels in 9 boxes of BioGlue...

Date: May 19, 2017
Company: CryoLife, Inc.
Status: Terminated
Source: FDA (Device)

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 Surgical Adhesive, Model/Catalog Number BG3510-5-J

Quantity: 705 single pack boxes

Why Was This Recalled?

The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.

Where Was This Sold?

Product distributed in Japan.

About CryoLife, Inc.

CryoLife, Inc. has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report