Recall Ledger

Octopus Evolution Tissue Stabilizer recall (Medtronic Perfusion Systems)

Medical deviceClass IIOngoing

Summary: Medtronic Perfusion Systems is recalling Octopus Evolution Tissue Stabilizer, Model TS2000. Reason: 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 is being recalled

Octopus Evolution Tissue Stabilizer, Model TS2000

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide - US Nationwide distribution.

How to tell if yours is affected

UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2575-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMay 12, 2026
ReportedJuly 1, 2026
CompanyMedtronic Perfusion Systems
Company locationBrooklyn Park, MN, United States
Initiated byVoluntary: Firm initiated
Quantity134 units

More recalls from Medtronic Perfusion Systems · all medical device recalls · recalls from May 2026

Official FDA record