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U.S. Department of Health and Human Services

Class 2 Device Recall OCS Liver System

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 Class 2 Device Recall OCS Liver Systemsee related information
Date Initiated by FirmJanuary 16, 2026
Date PostedNovember 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0383-2027
Recall Event ID 100065
PMA NumberP200031 
Product Classification Normothermic machine perfusion system for the preservation of donor livers prior to transplantation - Product Code QQK
ProductOCS Liver Perfusion Set Model/Catalog Number: 3200 OCS Liver Perfusion Sets containing OCS Liver Instrumentation Tool Set and OCS Liver Perfusion Termination Set, components of the Liver Perfusion Set (or available as separately shippable replacement accessories) intended to be used with the OCS console for organ transport.
Code Information 1. Accessory Set Lot: 4483-2-742422; Description: OCS Liver Instrumentation Tool Set; EXP Date: 2027-07-09; UDI: +B00944833/$$74483-2-742422/14D20270709K; 2. Accessory Set Lot: 4484-2-743965; Description: OCS Liver Perfusion Termination Set; EXP Date: 2027-08-04; UDI: +B00944843/$$74484-2-743965/14D20270804V;
FEI Number 3003152463
Recalling Firm/
Manufacturer		 TransMedics, Inc.
200 Minuteman Rd Ste 302
Andover MA 01810-1046
For Additional Information ContactChristy Foreman
978-809-8795
Manufacturer Reason
for Recall		Incorrectly assembled device sets with incorrect accessories.
FDA Determined
Cause 2		Process control
ActionOn or around January 16, 2026, "OCS Liver Perfusion Termination Set" and "OCS Liver Instrumentation Tool Set" letters were sent to customers. Actions to be taken: We request that you open sets and remove the affected set and replace with another unaffected set in your inventory. Please discard any unused sets from the affected lots. Please also check shelves, run bags and the entire hub for any sets with this lot number. Actions Taken by TransMedics We plan to ship replacement 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 Customer Service by phone at +1 (978) 552-0999 (US) or email (recall@transmedics.com).
Quantity in Commerce46
DistributionUS Nationwide distribution in the states of AZ, CA, CO, FL, GA, MA, MI, MN, NC, NJ, TX, WA.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = QQK
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