FDA Medical devices recall ·
Octopus Evolution Tissue Stabilizer, Model TS2000 recall
- Recall number
- Z-2575-2026
- Date
- (initiated May 12, 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
- 134 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Octopus Evolution Tissue Stabilizer, Model TS2000
Why was it recalled?
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.
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: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115
Distribution
Worldwide - US Nationwide 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-2575-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.