Lower riskMedical device recall · FDA · Published May 25, 2026
Medtronic Bio-Medicus Adult Cannula Kit Recall: Loose Foreign Material Risk
Medtronic recalls adult cannula kits with trace blood material that may cause loose foreign objects. Affected units include specific product numbers and lot numbers. Contact Medtronic for details.
“Medtronic Bio-Medicus Adult Cannula Kit Recall: Loose Foreign Material Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49072-medtronic-bio-medicus-adult-cannula-kit-recall-loose-foreign-material. Based on FDA recall #Z-2739-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2739-2026%22&limit=1).
Medtronic Perfusion Systems is recalling the Medtronic Bio-Medicus Adult Cannula Kit due to loose foreign material containing trace levels of blood. The Food and Drug Administration announced this voluntary Class II recall on May 25, 2026.
How to tell if you have it
Brand: Medtronic
Product: Medtronic Bio-Medicus Adult Cannula Kit
Product Number/CFN: 96530-115
MATNR/U DI/DI: 00643169769076
Lot Number: 230257001
The hazard
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. The agency classified the recall as Class II.
Context
GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since June 22, 2017. Other recent recalls of similar products include Medtronic Perfusion Systems EOPA 3D Arterial Cannula Recall (June 24, 2026), Medtronic Octopus Evolution AS Tissue Stabilizer Model TS2500 Recall (May 12, 2026), and Medtronic DLP Retrograde Cannula Recall (April 21, 2026). Other recent recalls of similar products include Medline Convenience Kits Recall (July 10, 2026) and Medline Airway Exam Kit Recall (February 16, 2026).
How to tell if you have this one
Check for product number CFN 96530-115 and lot number 230257001 on the cannula kit. The kit is used in cardiopulmonary bypass procedures.
Brand
Medtronic
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Verify the product number CFN 96530-115 and lot number 230257001 on the cannula kit.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Florida, Maryland, Michigan, North Carolina, Pennsylvania, Washington.
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2739-2026 (May 25, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2739-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.