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FDA
Food and Drug Administration · Recall Z-2739-2026 · May 25, 2026

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

Medtronic Perfusion Systems

The hazard

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. FDA Class II recall.

The remedy

Follow FDA guidance

About this recall

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

Affected identifiers

Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.

Model MATNR 00763000116019/UDI/DI 00643169769076Model Lot Number: 230257001UPC 00763000116019UPC 00643169769076

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Sourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.