Elevated site urgencyFDA Class II

Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115

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

Agency
FDA Device
Recall date
May 25, 2026
Status
Ongoing
Company
Medtronic Perfusion Systems

1. What product was recalled?

Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115

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

Code or lot text: MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001

LOT
Lot Number: 230257001
LOT
MATNR 00763000116019/UDI/DI 00643169769076
RECALL-NUMBER
Z-2739-2026

Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010

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

Code or lot text: MATNR A7630009466801/UDI/DI 20763000946689, Lot Numbers: 0231650870, C232227220

LOT
C232227220
LOT
Lot Numbers: 0231650870
LOT
MATNR A7630009466801/UDI/DI 20763000946689
RECALL-NUMBER
Z-2738-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

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

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

View source evidence for state distribution
  • Arkansas: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
  • California: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
  • Florida: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
  • Maryland: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
  • Michigan: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
  • North Carolina: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
  • Pennsylvania: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
  • Washington: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Device source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.