Compact Medical recalls certain ButterflyBVM resuscitators over bellows holes

Compact Medical has issued an urgent medical device recall notice for certain lots of its ButterflyBVM resuscitators after reporting that holes may develop in the devices’ bellows. The FDA said units from Lots 000109 through 000117 have a higher rate of holes than previously observed.

The FDA said customers should check whether their units are marked for removal or correction. Devices marked for removal should be taken out of use once a replacement BVM is in place. For devices marked for correction, users should perform the Pre-Use Test before every use and not use a unit that fails. A hole can allow tidal volume to leak instead of reaching the patient, causing inadequate ventilation and hypoxia, and potentially serious injury or death. As of November 2, 2026, Compact Medical had reported no serious injuries or deaths associated with the issue.