Medtronic Custom Perfusion Kits: Endotoxin Testing Not Performed
Medtronic recalls 48 specific perfusion kit models due to endotoxin testing not being conducted, which may pose a risk of infection in medical use.
Lower-risk recall
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
Contact the company
What happened, in plain English
Medtronic is recalling 48 different perfusion kit models because they were labeled as non-pyrogenic but endotoxin testing wasn't done. This could lead to infections in medical procedures if used improperly. Read more at govinfonow.com/recall/61692-medtronic-custom-perfusion-kits-endotoxin-testing-not-performed.
Source Summary by GovInfoNow · govinfonow.com/recall/61692-medtronic-custom-perfusion-kits-endotoxin-testing-not-performed · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0491-2022
Cite this page
“Medtronic Custom Perfusion Kits: Endotoxin Testing Not Performed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61692-medtronic-custom-perfusion-kits-endotoxin-testing-not-performed. Based on FDA recall #Z-0491-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0491-2022%22&limit=1).
Why it’s dangerous
These kits were labeled as non-pyrogenic (free from harmful proteins) but endotoxin testing wasn't performed. Endotoxins are bacterial components that can cause infections if introduced into the body during medical procedures.
Who’s affected
Healthcare professionals using these kits for medical treatments, particularly those in neonatal or pediatric care. Patients receiving transfusions or other medical procedures using these kits are at risk of infection.
How to tell if you have this one
Check for the model numbers listed in the recall: BB10Q85R, BB11C01R, B7H95R22, and others. Look for specific lot numbers and GTINs provided in the recall notice.
- Brand
Medtronic Perfusion Systems- Product
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM- Category
Medical device
What to do — step by step
Check Product Details
Identify the model number and lot numbers from the recall list to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, IL, IN, KY, MA, ME, MS, NY, OH, RI, TN, TX, and VA. The countries of Canada, Columbia, France, Germany, Italy, Netherlands, Saudi Arabia, Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, California, Connecticut, Illinois, Indiana, Kentucky, Maine, Massachusetts, Mississippi, New York, Ohio, Rhode Island, Tennessee, Texas, Virginia.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Why was endotoxin testing not performed?
The recall record states that endotoxin testing was not performed, but does not explain why.
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Where this comes from
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-0491-2022 (October 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0491-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.