Z-2738-2026 Class II Ongoing
FDA device recall Z-2738-2026 was initiated by Medtronic Perfusion Systems on May 25, 2026 and is designated Class II. Reason for recall: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2026
- Initiation Date
- May 25, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Reason for Recall
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Code Information
MATNR A7630009466801/UDI/DI 20763000946689, Lot Numbers: 0231650870, C232227220