CLASS II ONGOING Device recall · Reported 1 Jul 2026 · FDA Enforcement Report
Octopus Evolution Tissue Stabilizer recalled
Medtronic Perfusion Systems is recalling Octopus Evolution Tissue Stabilizer, distributed nationwide in the US. The recall was initiated on 12 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2575-2026
- FDA event ID
- 98966
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 May 2026
- FDA classified
- 24 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 May 2026 | Recall initiated by company | |
| 24 Jun 2026 | Classified by FDA | +43 days |
| 1 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Octopus Evolution Tissue Stabilizer, Model TS2000
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
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.
Which lots are affected?
UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98966This product is part of a recall event; the main page for the event is Octopus Evolution AS Tissue Stabilizer recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Octopus Evolution AS Tissue Stabilizer recalled | Medtronic Perfusion Systems | Other | Nationwide | |
| CLASS II | Octopus 4 Tissue Stabilizer recalled by Medtronic Perfusion Systems | Medtronic Perfusion Systems | Other | Nationwide |
More recalls from Medtronic Perfusion Systems
All 116| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Eopa Elongated One-Piece Arterial Cannula Blunt recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | EOPA Elongated One-Piece Arterial Cannula DIL TIP recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Eopa Elongated One-Piece Arterial Cannula Blunt recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | EOPA 3D Arterial Cannula DIL TIP, intended for use recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | EOPA 3D Arterial Cannula, intended for use recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
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| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |