Z-1473-2026 Class II Ongoing
FDA device recall Z-1473-2026 was initiated by Medtronic Perfusion Systems on January 13, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 939 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2026
- Initiation Date
- January 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 939 units
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.
Distribution Pattern
US Nationwide. Global Distribution.
Code Information
UDI-DI: 00763000543693; Lot Number: 0232837110, Additional lots as of 5/22/26: 0231547054 0231591827 0231758880 0231758898 0231758932 0231792414 0231792421 0231912903 0232670901 0232709219 0232709254 0232744928 0232784925 0232784989 0232805458