Moderate riskFDA DeviceNov 6, 2026Class II

TransMedics OCS Liver Perfusion Sets recalled for incorrect components

TransMedics is recalling certain OCS Liver Perfusion Sets because the device kits were incorrectly assembled and include incorrect components. The sets are used with the OCS console to transport donor livers. The FDA classified the recall as Class II, and no injuries have been reported.

From the FDA notice · Read the official notice ↗ · All TransMedics recalls

What to do

Check the perfusion set serial numbers and the Initiation and Termination Set lot numbers against the list in the notice, and set aside any matching products.
Contact TransMedics about the affected sets and your care team before deciding how to use them, since the notice does not say to stop using them on your own.
The notice does not state a remedy or replacement process; contact TransMedics for next steps.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected: 65
Illnesses reported: None reported
Manufactured in: 200 Minuteman Rd Ste 302, Andover, Massachusetts, United States
Classification: Class II
Recall number: Z-0385-2027

In the FDA's words

Description: 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 Incorrectly assembled device kits that include incorrect components. 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; 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. Affected quantity: 65
Hazard: Incorrectly assembled device kits that include incorrect components.

3 products in this recall

TransMedics OCS perfusion sets recalled for incorrect components

TransMedics recalled three OCS products: the OCS Heart Perfusion Set (Model 1200), the OCS Liver Perfusion Set (Model 3200), and the OCS Heart Instrumentation Tool Set (Model 1401). The FDA says the device kits were incorrectly assembled and include incorrect components. The recall was distributed nationwide in the US (NE, AZ, CA, FL, GA, IL, MA, MI, MN, NC, NJ, OH, TX, UT, WA) and in Australia, France, Italy and Taiwan. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

OCS Heart System OCS Heart Perfusion Set Model/Catalog Number: 1200 OCS Heart Perfusion Sets containing OCS Heart Cardioplegia Arrest Set are compon…
Z-0384-2027 · 5
OCS Liver System OCS Liver Perfusion Set Model/Catalog Number: 3200 OCS Liver Perfusion Sets containing OCS Liver Perfusion Initiation Set and OCS Liv… (this page)
Z-0385-2027 · 65
OCS Heart System OCS Heart Instrumentation Tool Set Model/Catalog Number: 1401 OCS Heart Instrumentation Tool Set, accessories intended to be used w…
Z-0386-2027 · 29