Z-2577-2026 Class II Ongoing

Recalled by Medtronic Perfusion Systems — Brooklyn Park, MN

FDA device recall Z-2577-2026 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: 590 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
590 units

Product Description

Octopus 4 Tissue Stabilizer, Model 29400

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: 00763000543679; Serial Numbers: 0231266463 0231468923 0231478249 0231478253 0231478260 0231651627 0231651634 0231651636 0231651637 0231651638 0231651639 0231651641 0231651642