- Recalling firm
- Medtronic Perfusion Systems
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 00643169668904, 00613994764379; Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199
- Units affected
- 288 units
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Firm location
- Brooklyn Park, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2576-2026
- Recall initiated
- May 12, 2026
- FDA classification date
- June 24, 2026
- FDA report date
- July 1, 2026
- FDA event ID
- 98966
- Last updated on HTM Vibe
- July 23, 2026