← Back to recalls

Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula

Class II
Recalling firm
Medtronic Perfusion Systems
Reason for recall
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Affected products (lot / model / serial)
MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
Distribution pattern
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Firm location
Brooklyn Park, MN, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2739-2026
Recall initiated
May 25, 2026
FDA classification date
July 15, 2026
FDA report date
July 22, 2026
FDA event ID
99199
Last updated on HTM Vibe
July 28, 2026
View on openFDA