Class 2 Device Recall OCS Liver System

• Date Initiated by Firm: April 18, 2025
• Date Posted: November 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0385-2027
• Recall Event ID: 100066
• PMA Number: P200031
• Product Classification: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation - Product Code QQK
• Product: OCS Liver System OCS Liver Perfusion Set Model/Catalog Number: 3200 OCS Liver Perfusion Sets containing OCS Liver Perfusion Initiation Set and OCS Liver Perfusion Termination Set, components of perfusion set (or available as separately shippable replacement accessories) intended to be used with the OCS console for organ transport
• Code Information: 1. Perfusion Set SN: 4470-2-17530; Description: Liver Perfusion Set; Accessory Kit Lot: 4482-2-735420; EXP Date: 2026-10-23; UDI: +B00944705/$$+74470-2-17530/14D202610230; 2. Perfusion Set SN: 4470-2-15571; Description: Liver Perfusion Set; Accessory Kit Lot: 4484-1-730259; EXP Date: 2026-04-19; UDI: +B00944705/$$+74470-2-15571/14D20260419E; 3. Perfusion Set SN: 4470-2-15587; Description: Liver Perfusion Set; Accessory Kit Lot: 4484-1-730259; EXP Date: 2026-04-19; UDI: +B00944705/$$+74470-2-15587/14D20260419E; 4. Accessory Set Lot: 4482-1-731653; Description: OCS Liver Perfusion Initiation Set; EXP Date: 2026-06-11; UDI: +B00944823/$$74482-1-731653/14D20260611C; 5. Accessory Set Lot: 4482-1-731670; Description: OCS Liver Perfusion Initiation Set; EXP Date: 2026-06-11; UDI: +B00944823/$$74482-1-731670/14D20260611B; 6. Accessory Set Lot: 4482-2-735420; Description: OCS Liver Perfusion Initiation Set; EXP Date: 2026-10-23; UDI: +B00944823/$$74482-2-735420/14D20261023; 7. Accessory Set Lot: 4484-1-730259; Description: OCS Liver Perfusion Termination Set; EXP Date: 2026-4-19; UDI: +B00944843/$$74484-1-730259/14D20260419N; 8. Accessory Set Lot: 4484-1-733061; Description: OCS Liver Perfusion Termination Set; EXP Date: 2026-07-21; UDI: +B00944843/$$74484-1-733061/14D20260721D
• FEI Number: 3003152463
• Recalling Firm/ Manufacturer: TransMedics, Inc.; 200 Minuteman Rd Ste 302; Andover MA 01810-1046
• For Additional Information Contact: Christy Foreman; 978-8098795
• Manufacturer Reason for Recall: Incorrectly assembled device kits that include incorrect components.
• FDA Determined Cause: Mixed-up of materials/components
• Action: On or about April 18, 2026, "OCS Heart Cardioplegia Arrest Set", "OCS Heart Instrumentation Tool Set", and "OCS Liver Perfusion Initiation Set" letters were sent to customers. Actions to be taken: TransMedics requests that you return or discard any unused affected units to us at your convenience. Actions Taken by TransMedics We have shipped units to you to replace the affected product. If you have any questions, please contact myself at the number below, your local support representative, or TransMedics Customer Service by phone at +1 (978) 552-0999 (US), +31(0) 20-7084561 (EU) or email (recall@transmedics.com).
• Quantity in Commerce: 65
• Distribution: Worldwide - US Nationwide distribution in the states of NE, AZ, CA, FL, GA, IL, MA, MI, MN, NC, NJ, OH, TX, UT, WA and the countries of Australia, France, Italy, Taiwan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = QQK