Class II U.S. Food and Drug Administration

Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115 recall: Medtronic received two complaints of loose foreign material confirmed

Recall published 3 months ago

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

The hazard: Foreign material — foreign objects

Fragments of foreign objects may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

What the notice says: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2739-2026
Published
July 22, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic Perfusion Systems
Product type
Medical devices
Distribution
Nationwide
Made in
United States
Lot / code info
MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
UPC codes
00763000116019, 00643169769076

Products covered by this recall

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

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00763000116019
  • 00643169769076

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 230257001

Model or item number

On the rating label, the box or the instruction sheet.

  • CFN 96530-115

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Foreign material

Medtronic Perfusion Systems — Fragments of foreign objects may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.
  3. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.
  4. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Company contact: Medtronic Perfusion Systems — 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic Perfusion Systems medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00763000116019, 00643169769076; lot code 230257001; model number CFN 96530-115. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls