CryoLife Pulmonary Cardiac Branch Recalled Due to Morphine Presence
CryoLife, Inc. is recalling one unit of Cryopatch SG Pulmonary Human Cardiac Branch because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a hazardous substance (morphine) was detected in the donor, representing a risk of harm even though specific injuries or illnesses have not been reported in the source text.
Plain-English summary
CryoLife, Inc. is recalling one unit of the Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020, Serial Number 10988328. The device was distributed to facilities in Arkansas and Ohio.
The recall was initiated because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine. Although the device met FDA and AATB eligibility criteria at the time of distribution, the subsequent toxicology findings necessitated the recall.
Healthcare facilities that received this specific unit should contact CryoLife, Inc. for instructions on how to return or dispose of the product.
The recalled product
- Product
- Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
- Manufacturer
- CryoLife, Inc.
- Category
- Medical Device — Cardiac Tissue
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number 10988328
Distribution
Part of a larger recall action
This product is one of 2 recalled by CryoLife, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · CryoLife, Inc.
See all →- ModerateBioGlue Surgical Adhesive recalled for unauthorized distribution in European Union
FDA (Devices) · 2021-12-22
- HighCryoLife Recalls CryoValve SG Pulmonary Heart Valves Due to Microbial Test Failures
FDA (Devices) · 2020-12-30
- SevereCryoLife Recalls CryoPatch SG Pulmonary Human Cardiac Patch Units
FDA (Devices) · 2020-12-30
- SevereCryoLife Pulmonary Hemi-Artery Patch Recalled for Donor Infection
FDA (Devices) · 2019-05-01
- LowCryoLife Recalls Two On-X Aortic Heart Valves for Mislabeled Serial Numbers
FDA (Devices) · 2019-04-03
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- SevereCryoLife Recalls CryoPatch SG Pulmonary Human Cardiac Patch Units
FDA (Devices) · 2020-12-30
- SevereCryoLife Pulmonary Hemi-Artery Patch Recalled for Donor Infection
FDA (Devices) · 2019-05-01
- HighCryoLife Pulmonary Hemi-Artery SG Recalled Due to Donor Testing Concerns
FDA (Devices) · 2014-01-29
- HighCryoLife Recalls CryoValve SG Pulmonary Heart Valves Due to Microbial Test Failures
FDA (Devices) · 2020-12-30
- ModerateCryoLife Pulmonary Hemi-Artery Graft Recalled for Labeling Error
FDA (Devices) · 2018-10-24
- HighCryoValve SG Heart Valve Recalled for Staphylococcus aureus Contamination
FDA (Devices) · 2024-04-24