RecallRadar

FDA Device recall Z-1473-2026

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

On 2026-03-04 the FDA classified a Class II recall of Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 by Medtronic Perfusion Systems, citing 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,….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1473-2026
ClassificationClass II
Statusongoing
Initiated2026-01-13
Published2026-03-04
Last updated2026-09-13 11:58 UTC
CompanyMedtronic Perfusion Systems
DistributionUS

Product

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

Reason

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.

Identifiers

code_info
UDI-DI: 00763000543693; Lot Number: 0232837110, Additional lots as of 5/22/26: 0231547054 0231591827 0231758880 02317…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

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-1473-2026%22

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