FDA issues alert for Compact Medical ButterflyBVM resuscitators over air leak risks
On November 3, 2026, the FDA issued an Early Alert regarding a recall and correction notice for certain Compact Medical ButterflyBVM Single-Use Bag-Valve-Mask Resuscitators. These emergency devices provide manual breathing support to patients. Compact Medical reported that holes can develop in the flexible bellows of the mask, allowing air to leak out instead of reaching the patient. This leak can lead to inadequate ventilation and hypoxia, a condition where body tissues lack oxygen, which may cause serious injury or death. The alert covers two separate groups of lot numbers. Lots 000109 through 000117 must be removed from service as soon as replacement devices are present. Lots 000081 through 000108 require a safety test before every use. Compact Medical sent initial customer letters on September 26, 2026. As of November 2, 2026, no serious injuries or deaths have been reported.
What was announced
The FDA published a safety alert following action by manufacturer Compact Medical regarding its ButterflyBVM Single-Use Bag-Valve-Mask Resuscitators. These handheld devices supply air to patients who need emergency respiratory support.
Compact Medical identified that holes can form in the device bellows, which is the squeezable chamber that pumps air. Lots 000109 through 000117 show a higher rate of these holes than previously seen. The manufacturer instructs healthcare staff to remove these specific lots from carts, vehicles, and stations, but only after securing a replacement mask first.
For lots 000081 through 000108, Compact Medical issued a correction rather than a complete removal. Medical staff must perform a Pre-Use Test on these units immediately before placing them on a patient. If a unit fails the test, staff must label it "DO NOT USE" and switch to a backup resuscitator.
What it means
A hole in the bellows creates an air leak. When a user squeezes the mask, air escapes into the room rather than moving into the lungs. This loss of delivered air volume, called tidal volume, can cause hypoxia. Left uncorrected, severe oxygen deprivation leads to serious harm or death.
Responders and clinical staff who use these devices must check their inventory immediately. If packaging is missing and the lot number cannot be verified, the FDA advises assuming the unit is part of the affected lots. Devices that fail during patient care or connect to a patient injury must not be destroyed. Instead, staff should quarantine these specific units with their original packaging and report them directly to Compact Medical.
What the announcement does not tell us
The announcement does not state what manufacturing flaw or material failure causes holes to form in the bellows. It also does not clarify how many total individual units were produced across the affected lot numbers.
While Compact Medical reported no serious injuries or deaths as of November 2, 2026, the alert does not specify if any minor incidents occurred during active patient care. Finally, the notice does not mention a timeline for when replacement resuscitators will reach all customer locations.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is FDA MedWatch Safety Alerts’s own. Always check the original before acting on anything here.
Compact Medical removes and updates use instructions for certain ButterflyBVM devices due to development of holes in bellows.
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