Quick Facts at a Glance
- Recall Date
- May 12, 2026
- Hazard Level
- HIGH
- Brand
- Medtronic Perfusion Systems
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medtronic Perfusion Systems
- Model numbers
- UDI-DI: 00643169668904, 00613994764379, Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 12, 2026
Reported by FDA DEVICE
July 1, 2026
RecallRadar source check
July 7, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Perfusion Systems or your healthcare provider for instructions. Notification method: Letter
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Full Description
Octopus Evolution AS Tissue Stabilizer, Model TS2500. Reason: 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.. Classification: Class II. Quantity: 288 units. Distribution: Worldwide - US Nationwide distribution.
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Safety Guide
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Read: How to Get Refunds and ReplacementsWant to Know First?
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