Class II

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

Medtronic Perfusion Systems · May 25, 2026

Reason for Recall

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Distribution

Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.

States Affected

NATIONWIDE

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2739-2026

Status: ongoing

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