Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

Recall Insight

This FDA Devices action (record #Z-0439-2021) was formally reported on November 18, 2020, with the manufacturer initiating the action on September 12, 2020. It is classified under Moderate severity (Class II), with a current status of Completed. Fresenius Medical Care Holdings, Inc. is listed as the recalling firm, operating out of Waltham, MA. Federal records indicate 9,907 devices units are affected.

The documented reason for this recall is: The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not … Distribution data in the federal record shows the product reached: Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Dev…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.