- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Certain lots of product have the potential for a sterile barrier breach.
- Affected products (lot / model / serial)
- GTIN 00643169454521, Lot Numbers: 0231545565, C231958117; GTIN 20643169454525, Lot Numbers: 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958117, C231958118, C231958119, C231958120, C232287623.
- Units affected
- 6572 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
- 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-2215-2026
- Recall initiated
- April 21, 2026
- FDA classification date
- May 20, 2026
- FDA report date
- May 27, 2026
- FDA event ID
- 98786
- Last updated on HTM Vibe
- July 23, 2026