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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 FirmNovember 20, 2025
Date PostedNovember 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0389-2027
Recall Event ID 100092
PMA NumberP200031 
Product Classification Normothermic machine perfusion system for the preservation of donor livers prior to transplantation - Product Code QQK
ProductOCS Liver System for organ transport OCS Liver Perfusion Set Model/Catalog Number: 3200 Product Description: The recalled product is a standard off the shelf syringe. It is used as part of solution delivery cassette (SDS Cassette) to be used with the perfusion module of OCS Liver System. OCS Liver Perfusion Sets within the serial number range between 4470-3-18076 and 4470-3-20343 may contain SDS cassettes within the impacted lot range of 4459-6-737116 to 4459-6-739965. Each Liver Perfusion Set contains three SDS cassettes. The BD syringe is a component of SDS Cassette PN 100004459, which is an accessory of the Liver Perfusion Set.
Code Information OCS Liver Perfusion Set Serial Numbers from 4470-3-18076 to 4470-3-20343;
FEI Number 3003152463
Recalling Firm/
Manufacturer		 TransMedics, Inc.
200 Minuteman Rd Ste 302
Andover MA 01810-1046
For Additional Information ContactChristy Foreman
978-8098795
Manufacturer Reason
for Recall		Faulty Solution Delivery System (SDS) Cassettes within the device set were assembled with syringes that were manufactured with an atypical lubricant, which results in sub-par performance and has the potential to cause leaks.
FDA Determined
Cause 2		Component change control
ActionOn or about November 20, 2025, "OCS Liver Solution Delivery (SDS) Cassettes" letters were sent to customers: Actions to be taken: TransMedics requests that you discard any unused, affected, SDS Cassettes. 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 TransMedics Customer Service by phone at +1 (978) 552-0999 (US), +31(0) 20-7084561 (EU) or email (recall@transmedics.com).
Quantity in Commerce1179 (Liver Perfusion Sets)
DistributionWorldwide - US Nationwide distribution in the state of NE and the country of Italy.
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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