FDA recall, , Moderate risk
Medtronic DLP and Bio-Medicus Cannulas
The Medtronic DLP One-Piece Pediatric Arterial Cannula may contain loose foreign material with trace blood.
Summary by Recall Canary from the FDA notice
What happened
Medtronic Perfusion Systems of Brooklyn Park, Minnesota, recalled the Medtronic Bio-Medicus Adult Cannula Kit and the Medtronic DLP One-Piece Pediatric Arterial Cannula after receiving two complaints of loose foreign material confirmed as containing trace levels of blood. The recall began May 25, 2026, and was added to the FDA's Enforcement Report on July 15, 2026.
Distribution included Maryland, California, Michigan, Washington, Pennsylvania, North Carolina, Florida and Arkansas, as well as worldwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
2 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
- UDI-DI
- 00763000116019
- 00643169769076
- 230257001
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
- UDI-DI
- 20763000946689
- 0231650870
- Lot code
- C232227220
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Maryland, California, Michigan, Washington, Pennsylvania, North Carolina, Florida, Arkansas.
- Company
- Medtronic Perfusion SystemsBrooklyn Park, Minnesota
- Hazard
- Foreign object
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99199
- Recall numbers
- Z-2738-2026 to Z-2739-2026
All recalls from Medtronic Perfusion Systems
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
