Moderate riskFDA DeviceNov 6, 2026Class II

TransMedics OCS Lung perfusion set recalled for possible startup error

TransMedics is recalling the OCS Lung Mission Critical Plus Perfusion Set, model 2200, software rev 1, which is used to transport donor lungs. The Perfusion Module may have an unprogrammed Front End Board, which may cause the OCS system to show an "Unsupported Perfusion Module Present" error and block further use. No injuries have been reported.

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

What to do

Contact TransMedics and your transplant care team before using the affected perfusion set.
Affected unit: Perfusion Set serial SN 6790-2-23967, expiration 11/21/2027, UDI +B00967905/$$+76790-2-23967/14D20271121L.
The notice does not specify a remedy; ask TransMedics how to get a correction or replacement.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: OCS Lung Mission Critical Plus Perfusion Set Model/Catalog Number: 2200 Software Version: rev 1 OCS Lung MC+ Perfusion Module included in the Lung MC+ Perfusion Set used 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: 1
Illnesses reported: None reported
Manufactured in: 200 Minuteman Rd Ste 302, Andover, Massachusetts, United States
Classification: Class II
Recall number: Z-0382-2027

In the FDA's words

Description: OCS Lung Mission Critical Plus Perfusion Set Model/Catalog Number: 2200 Software Version: rev 1 OCS Lung MC+ Perfusion Module included in the Lung MC+ Perfusion Set used for organ transport. The Perfusion Module may have an unprogrammed Front End Board (FEB) which will not allow the system to proceed beyond the initial startup process. The OCS system will display an error message saying Unsupported Perfusion Module Present and will prevent further system use. Perfusion Set SN 6790-2-23967; Description - OCS Lung Mission Critical Perfusion Set; EXP Date - 11/21/2027; UDI: +B00967905/$$+76790-2-23967/14D20271121L; Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, IL, MA, MN, NC, NE, NY, TX and the country of Serbia;. Affected quantity: 1
Hazard: The Perfusion Module may have an unprogrammed Front End Board (FEB) which will not allow the system to proceed beyond the initial startup process. The OCS system will display an error message saying Unsupported Perfusion Module Present and will prevent further system use.

3 products in this recall

TransMedics OCS perfusion sets recalled for possible startup failure

TransMedics is recalling three OCS organ perfusion sets used for organ transport: the OCS Heart Perfusion Set (Model 1200, software rev 3), the OCS Liver Perfusion Set (Model 3200, software rev 3), and the OCS Lung Mission Critical Plus Perfusion Set (Model 2200, software rev 1). The perfusion module in these sets may have an unprogrammed Front End Board, which can stop the system from getting past startup and cause it to show the error "Unsupported Perfusion Module Present." The notice says the product was distributed worldwide, including nationwide in the US in several states and in Serbia, and reports no injuries.

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

OCS Heart Perfusion Set Model/Catalog Number: 1200 Software Version: rev 3 Product Description: OCS Heart Perfusion Module, included in the Heart Perfu…
Z-0380-2027 · 6
OCS Liver Perfusion Set Model/Catalog Number: 3200 Software Version: rev 3 OCS Liver Perfusion Module included in the Liver Perfusion Set used for org…
Z-0381-2027 · 18
OCS Lung Mission Critical Plus Perfusion Set Model/Catalog Number: 2200 Software Version: rev 1 OCS Lung MC+ Perfusion Module included in the Lung MC+ Per… (this page)
Z-0382-2027 · 1