TransMedics recalls

TransMedics is recalling three OCS Liver System products: Liver Perfusion Sets (model 3200), Liver Solution Infusion Sets (model 3457), and Solution Delivery Cassettes (model 1467). The cassettes were assembled with syringes made with an atypical lubricant, which may cause sub-par performance and has the potential to cause leaks. The recall covers 1,179 perfusion sets, 90 infusion sets and 55 cassettes, distributed nationwide in Nebraska and to Italy, and no injuries have been reported.

Moderate·FDA·Nov 6, 20263 products

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.

Moderate·FDA·Nov 6, 20263 products

This recall covers 46 TransMedics OCS Liver Perfusion Sets (model 3200), which were incorrectly assembled and contain incorrect accessories. The sets were distributed in 12 states, and no injuries have been reported.

Moderate·FDA·Nov 6, 2026

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.

Moderate·FDA·Nov 6, 20263 products