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# FDA Warns of Ventilation Failures in ButterflyBVM Resuscitators
- URL: https://www.fdaweb.com/fda-warns-of-ventilation-failures-in-butterflybvm-resuscitators/
- Published: 2026-11-04T00:05:00.000Z
- Updated: 2026-11-04T00:13:06.000Z
- Author: David McFarland
- Tags: Devices

FDA has issued an Early Alert concerning a potentially high-risk defect in Compact Medical's ButterflyBVM bag-valve-mask resuscitators that could cause inadequate ventilation, hypoxia, serious injury or death.

The [agency said](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-compact-medical-removes-and-updates-use-instructions-butterflybvm-bag-valve-mask?utm%5Fmedium=email&utm%5Fsource=govdelivery) Compact Medical is removing certain lots of the single-use devices and requiring additional pre-use testing for others after identifying a risk that holes may develop in the devices' bellows, allowing air intended for the patient to escape.

As of 11/2, the company had reported no serious injuries or deaths associated with the problem.

ButterflyBVM devices are used for manual pulmonary resuscitation and emergency respiratory support.