Medtronic Octopus Evolution Tissue Stabilizer recalled for incorrect tubing assembly
Medtronic Octopus Evolution Tissue Stabilizer recalled for assembly error
Medtronic identified a manufacturing defect in certain Octopus Evolution Tissue Stabilizer units where the tubing was installed backwards: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This incorrect assembly could affect the device's proper function during use.
- Check your device serial number against the affected list: 0232992409, 0233010063, 0233010115
- Contact Medtronic if you have an affected unit for instructions on replacement or return
- Do not use the device if you believe it is affected
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2575-2026More Medtronic recalls
- FDA-Device2026-07-22Medtronic DLP One-Piece Pediatric Arterial Cannula recalled for loose foreign material with blood
- FDA-Device2026-07-22Medtronic Bio-Medicus Adult Cannula Kit recalled for loose foreign material with blood
- FDA-Device2026-07-01Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
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