FDA Device recall Z-2575-2026
Octopus Evolution Tissue Stabilizer, Model TS2000
- FDA Device
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of Octopus Evolution Tissue Stabilizer, Model TS2000 by Medtronic Perfusion Systems, citing 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 ca….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2575-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-12 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
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.
Identifiers
| code_info | UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2575-2026%22
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