FDAFDA recall Z-2739-2026 · Jul 22, 2026
Medtronic Perfusion Systems: Medtronic Bio-Medicus Adult Cannula Kit recall
Recall found
Product
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Reason for recall
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-25
Source: openFDA enforcement record Z-2739-2026 · search recall number Z-2739-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.