FDAFDA recall Z-2575-2026 · Jul 1, 2026
Medtronic Perfusion Systems: Octopus Evolution Tissue Stabilizer recall
Recall found
Product
Octopus Evolution Tissue Stabilizer, Model TS2000
Reason for recall
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115
- Quantity
- 134 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-12
Source: openFDA enforcement record Z-2575-2026 · search recall number Z-2575-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.