FDA Medical devices recall ·
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system… recall
- Recall number
- Z-1473-2026
- Date
- (initiated January 13, 2026)
- Company / brand
- Medtronic Perfusion Systems
7611 Northland Dr N, Brooklyn Park, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 939 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide. Global Distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1473-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.