UnratedMedical device recall · FDA · Published May 14, 2018
CryoLife Cryovalve SG Pulmonary Heart Valve Recall: Morphine in Urine Found
CryoLife recalls Cryovalve SG Pulmonary Heart Valve (Catalog SGPVVOO) after autopsy reports found morphine in patient urine. This may indicate improper use or contamination.
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Take action
Contact the company
📍Recalling firmCryoLife, Inc.1655 Roberts Blvd NW · Kennesaw, GA 30144-3632
“CryoLife Cryovalve SG Pulmonary Heart Valve Recall: Morphine in Urine Found.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71078-cryolife-cryovalve-sg-pulmonary-heart-valve-recall-morphine-in-urine. Based on FDA recall #Z-2271-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2271-2018%22&limit=1).
The FDA announced on May 14, 2018, that CryoLife, Inc. voluntarily recalled one Cryovalve(R) SG Pulmonary Human Heart Valve due to the presence of morphine in the urine of the donor. The device was distributed in Arkansas and Ohio.
How to tell if you have it
Brand: CryoLife
Product: Cryovalve(R) SG Pulmonary Human Heart Valve
Catalog Number: SGPVVOO
Serial Number: 10988203
The hazard
Final autopsy and toxicology reports indicated the presence of morphine in the urine of the donor from which the device was obtained. The devices met FDA and AATB eligibility criteria but were distributed despite this finding.
Context
GovInfoNow's records show CryoLife, Inc. has five other recalls on record since June 4, 2018. Other recent recalls of similar products include Paradise Ultrasound Renal Denervation Catheter Recall (Jan. 29, 2026), Medline Heart Cath Pack-LF Kits Recall (March 24, 2026), and Avanos Medical PEG Kit 20 Fr PUSH OTW Recall (April 30, 2026).
How to tell if you have this one
Check for the product name 'Cryovalve SG Pulmonary Human Heart Valve' and catalog number SGPVVOO. The specific serial number 10988203 is also listed in the recall.
Brand
CryoLife
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
AR, OH
Recall number
Product, codes & lots
Z-2271-2018
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO; Serial Number 10988203
Z-2272-2018
Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020; Serial Number 10988328
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the catalog number SGPVVOO and serial number 10988203 on the device.
Where it went and when
Where it was distributed
Distributed in Arkansas and Ohio.
Listed by the agency
Not listed
FDA distribution: “AR, OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, Ohio.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2271-2018 (May 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2271-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.