The FDA issued an early alert on November 3, 2026, warning emergency responders—including hospitals and ambulance services—to stop using specific ButterflyBVM bag-valve-mask resuscitators due to an unexpectedly high incidence of bellows defects.
A bag-valve-mask is a manual device that rescuers operate by hand to deliver air into the lungs of someone who cannot breathe independently. The FDA warned that if a hole appears in the bellows, the tidal volume might escape from the device rather than being delivered to the patient.
The agency explained that such a leak can result in insufficient ventilation and low oxygen levels (hypoxia), potentially leading to serious harm or fatality. As of November 2, Compact Medical had not received any reports of serious injuries or deaths linked to this problem.
Affected Devices
The alert splits affected devices into two groups. Nine lots, numbered 000109 through 000117, have shown a higher rate of bellows holes than previously observed and are being removed.
These lots include ButterflyBVM, READY units (SKUs R300 and R308) in lots 000109, 000110, 000111, 000112, 000113, 000115, 000116, and 000117, and standard ButterflyBVM units (SKUs A100 and A108) in lot 000114.
Read Also: New Mexico Hosts Aid Sessions Amid Medicaid Work Rule Changes
A second, larger group of 22 lots needs added safety steps rather than removal. It covers 14 lots of the READY model, four lots of the standard model, and four lots of the ButterflyBVM, PLUS (SKUs P200 and P208), with lot numbers ranging from 000081 to 000108.
Facilities should verify their inventory against the complete list of lot and device identifiers on the FDA website. For the lots being removed, the FDA’s first step is to ensure replacement bag-valve-masks are available before taking any units out of service.
Users should then stop using and remove all affected units, including those in stations, vehicles, crash carts, and storage, quarantine them, and mark them “DO NOT USE.” Any unit that failed during patient use or is linked to an injury should not be destroyed; it should be quarantined with its original packaging, and Compact Medical should be contacted for instructions.
Device Background
The ButterflyBVM is a single-use resuscitator with dials that let rescuers set a maximum tidal volume and a peak inspiratory pressure limit, which is meant to reduce the risk of over-ventilation. Instead of squeezing a round bag, users squeeze the device’s side arms together with one or two hands.
The FDA cleared it on April 25, 2025, according to the agency’s 510(k) clearance record for the device. According to the 510(k) summary filed with the FDA, the device is indicated for adults, adolescents, children, and infants in hospitals and other professional health care facilities, and for those groups plus newborns in transport and non-hospital emergency settings such as EMS.
Read Also: Higher opioid doses do not worsen newborn withdrawal
Equipment managers should check every location where a unit might be kept and document which lots they hold. Most members of the public will never handle a bag-valve-mask. Bystanders who see a teen or adult suddenly collapse can still help by following the American Heart Association’s two steps of Hands-Only CPR: call 911 and push hard and fast in the center of the chest.
U.S. customers with questions, quality problems, or adverse reactions should contact Compact Medical at [email protected]. Health care professionals and consumers can also report problems to the FDA through its MedWatch online reporting form. The FDA uses early alerts to notify the public of potentially high-risk device issues, and the agency said it will update the alert as significant new information becomes available, with the current focus on the ButterflyBVM lots 000109 through 000117.
Reporting Problems
The device is rated to operate from minus 18 to 50 degrees Celsius.
The early alert does not say how many units were distributed or where, and it does not explain what causes the holes. Distributors have been told to stop distributing lots 000109 through 000117. Compact Medical is updating use instructions for a second group of lots.
