Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

Recall Insight

This FDA Devices action (record #Z-2140-2021) was formally reported on August 4, 2021, with the manufacturer initiating the action on July 14, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Maquet Medical Systems USA is listed as the recalling firm, operating out of Wayne, NJ. Federal records indicate 33 units are affected.

The documented reason for this recall is: There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species. Distribution data in the federal record shows the product reached: Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.. 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 5 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.