Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

FDA Recall #Z-1473-2026 — Class II — January 13, 2026

Recall #Z-1473-2026 Date: January 13, 2026 Classification: Class II Status: Ongoing

Product Description

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Reason for Recall

During the manufacturing, 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.

Recalling Firm

Medtronic Perfusion Systems — Brooklyn Park, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2 units

Distribution

US Nationwide distribution in the states of FL and IN.

Code Information

UDI-DI: 00763000543693; Lot Number: 0232837110

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated