FDA posted two warning letters on June 30, 2026, both dated May 20 and both arising from an inspection run December 1 to 10, 2025. One went to BMC Medical in Beijing, the other to 3B Medical in Dublin, Ohio. The devices are sleep apnea machines originally cleared under K153387 in September 2016.
The BMC letter is a software change case. FDA said firmware updates added detection algorithms for flow limitation, respiratory effort-related arousals and periodic breathing, and that the company also changed the sound abatement system, the circuit board chip and the master control software. In FDA's reading those changes required a new 510(k) before distribution. Separately, a firmware update from G3-2.00.76 to G3-2.00.77 addressed unexpected shutdowns during therapy and was never reported as a correction within 10 working days.
The 3B letter reads as a quality system case. FDA said the company distributed devices whose intended use had expanded from single-patient use to multi-patient reuse in hospital and institutional settings without a new submission, cancelled or misclassified complaints that met the regulatory definition including choking and shortness of breath reports, and let the iCodeConnect software carry a 2016 risk management report that never assessed changes made from 2018 through 2025.
Both findings are ordinary and both are avoidable. A letter-to-file that concludes no new 510(k) is needed has to actually analyse the new algorithm against the cleared indications, and a firmware push that fixes a safety behaviour is a correction whether or not anyone calls it a recall.