FDA-Device2026-07-01Class II
Octopus Evolution Tissue Stabilizer, Model TS2000
Hazard
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
134 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
Octopus Evolution Tissue Stabilizer, Model TS2000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2575-2026More Medtronic Perfusion Systems recalls
- FDA-Device2026-07-01Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for potential sterile barrier breach
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