Official recall notice

FDA DeviceClass IINotable

FDA Recall: Octopus Evolution AS Tissue Stabilizer, Model TS2500

Recall date
2026-07-01
FDA class
Class II

Why it was recalled

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.

Product description

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.

Affected products

UDI-DI: 00643169668904, 00613994764379; Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199

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