FDAFDA recall Z-2577-2026 · Jul 1, 2026
Medtronic Perfusion Systems: Octopus 4 Tissue Stabilizer recall
Recall found
Product
Octopus 4 Tissue Stabilizer, Model 29400
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: 00763000543679; Serial Numbers: 0231266463 0231468923 0231478249 0231478253 0231478260 0231651627 0231651634 0231651636 0231651637 0231651638 0231651639 0231651641 0231651642
- Quantity
- 590 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-2577-2026 · search recall number Z-2577-2026 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.