Class II — Potential Health Hazard

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

CryoPatch SG Pulmonary Hemi-Artery Patch Recalled by CryoLife, Inc. Due to The device is recalled due to donor ineligibility...

Date: November 21, 2016
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

CryoPatch SG Pulmonary Hemi-Artery Patch

Quantity: 1

Why Was This Recalled?

The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.

Where Was This Sold?

Product was shipped to Texas

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