FDA Medical devices recall ·
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115 recall
- Recall number
- Z-2739-2026
- Date
- (initiated May 25, 2026)
- Company / brand
- Medtronic Perfusion Systems
7611 Northland Dr N, Brooklyn Park, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Hazard tags
- Foreign material
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Why was it recalled?
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Arkansas California Florida Maryland Michigan North Carolina Pennsylvania Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2739-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.