Z-2575-2026 Class II Ongoing
FDA device recall Z-2575-2026 was initiated by Medtronic Perfusion Systems on May 12, 2026 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 134 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- May 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 134 units
Product Description
Octopus Evolution Tissue Stabilizer, Model TS2000
Reason for Recall
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115