“Nontuberculous mycobacteria (NTM) patient infections, NTM device contamination and, in some cases, both issues have now been reported for all manufacturers of heater-cooler devices in the U.S.,” the FDA noted.

The company said unused devices should be sent to a Smith & Nephew agency or distributor.

Use of the defective devices could lead to patient injury or death, the agency warned, noting that 1,186 issues and a single injury have been reported so far.