FDAFDA · Food and drugs·Recall number Z-2576-2026
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Published July 1, 2026 · Recall initiated: May 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Perfusion Systems
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- UDI-DI: 00643169668904, 00613994764379; Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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