Sterile barrier breach in a cardiac surgery cannula (Z-2218-2026) — what fails is not the product but the assurance around it
A vascular catheter used in cardiopulmonary bypass recalled because certain lots have the potential for a sterile barrier breach. The quantity is 2,620 units and distribution spans the United States and more than thirty other countries.
Recall overview (primary data)
- ClassificationClass II
- Product typeMedical Device
- Recalling firmMedtronic Perfusion Systems
- ReasonCertain lots of product have the potential for a sterile barrier breach.
- DistributionWorldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia...
- Recall initiated2026-04-21
Key points
- A cardiopulmonary bypass catheter was recalled because certain lots have the potential for a sterile barrier breach.
- The issue is not a defect in the product but the loss of the assurance held by the packaging.
- Opening the packaging to check would end its sterility, so the response is a recall by lot.
- Across the unpublished records this site holds as of 2026-09-04, 203 cite sterility, the most numerous class.
- The quantity is 2,620 units with distribution across the United States and more than thirty other countries.
1Not the contents but the wrapping
The reason is not a defect in the product itself. It is that the sterile barrier — the packaging that holds a sterilized state — has the potential to be breached. An instrument entering the body presumes sterility, and the packaging is what assures it. Breached, the premise falls away.
That last line is what makes this class difficult. Opening the packaging to see whether it is breached leaves the product no longer sterile. Checking and spoiling are the same act, which is why the response is to recall by lot.
2How common sterility recalls are
Tallying the reason text across the unpublished records this site holds as of 2026-09-04, 203 mention sterility or sterilization, the most numerous class. For instruments entering the body or delivering medication into it, being sterile is a condition prior to function itself.
3Distribution scattered worldwide
The distribution field lists more than thirty countries. Devices are sold under each country regulation while manufacturing is often concentrated, so one lot scatters across the world. Notice of a recall reaches through each national distribution network in stages, and halting stock is done separately wherever it lands.
The records this site holds also include recalls confined to a single state, so the same format spans a wide range of scale.
4Why Class II
This is classified Class II. A non-sterile instrument entering the body could have serious consequences, yet classification turns on the harm judged likely to follow. That the breach is a potential rather than an established one, and that packaging condition is checked before use in practice, appear to enter that judgment.
Why it matters
Where assurance rests on packaging, the act of verifying destroys what it verifies, so decisions run by lot rather than by unit. Manufacturing concentrates while distribution scatters, so notice and stock holds proceed in stages.
FAQ
Why recall a whole lot rather than check?
Why is it Class II?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2218-2026