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Class IIOngoing

Medtronic Perfusion Systems recalls 2 products

Recall date · record updated Jul 22, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Medtronic Perfusion Systems
Reason
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99199…

Products (2)

  1. Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula

    Codes/lots: MATNR A7630009466801/UDI/DI 20763000946689, Lot Numbers: 0231650870, C232227220Recall no. Z-2738-2026Class II

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

    Codes/lots: MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001Recall no. Z-2739-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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