FDAClass IIJuly 1, 2026

Octopus Evolution AS Tissue Stabilizer recall

Octopus Evolution AS Tissue Stabilizer, Model TS2500

Why was Octopus Evolution AS Tissue Stabilizer recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Recalling firm
Medtronic Perfusion Systems
Quantity
288 units
Distribution
Worldwide - US Nationwide distribution.
Recall date
July 1, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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