FDA Flags ButterflyBVM Resuscitators Over Bellows Holes

FDA has issued an Early Alert for a manual resuscitator used in hospitals and by EMS crews, after the device maker found more bellows holes than expected in certain production lots. The November 3, 2026 alert covers Compact Medical's ButterflyBVM, a single-use bag-valve-mask resuscitator cleared by FDA in April 2025 — and it splits the response into two tiers: some lots come off the shelf entirely, and others stay in service only behind a new mandatory check.

What went wrong

The ButterflyBVM is a disposable, bellows-based manual resuscitator: a squeeze-bag device clinicians use to ventilate a patient who cannot breathe adequately on their own, with dials to set tidal volume and peak inspiratory pressure across patient sizes from neonate to adult. FDA's alert states that Compact Medical identified a higher rate of holes in the bellows than had previously been observed in certain lots. A hole in the bellows gives inspired air a path to escape before it reaches the patient, which can mean a resuscitation effort that looks like it is working — the bag compresses, the clinician feels resistance — while delivering less oxygen than intended.

A two-tier response

FDA's alert does not treat every affected lot the same way. Nine lots, numbered 000109 through 000117, showed the higher hole rate directly and are being pulled from use entirely. A larger set — twenty-two lots, numbered 000081 through 000108, including the ButterflyBVM PLUS variant — can remain in service, but only under a new condition: a pre-use test, described in the manufacturer's Instructions for Use, run before every single patient use, with a backup resuscitation device kept on hand in case a unit fails. That is a meaningfully different ask of a hospital or EMS crew than a straightforward recall: it converts a shelf item into one that requires a documented check immediately before each use, indefinitely, until Compact Medical says otherwise.

What facilities need to do

• Removed lots (000109–000117): pull from use and sale immediately; do not substitute the pre-use test for removal.
• In-service lots (000081–000108): run the pre-use test specified in the Instructions for Use before every patient use, and keep a backup bag-valve-mask device available at the point of care.
• Any unit that fails the test, or falls in a removed lot: label it “DO NOT USE,” keep it in its original packaging rather than discarding it, and contact Compact Medical using the information in the FDA alert for further instructions.
• FDA says it will update the Early Alert as significant new information becomes available; facilities with affected inventory should check the alert page periodically rather than treating today's instructions as final.

Frequently asked questions

What did FDA announce on November 3, 2026?

An Early Alert covering Compact Medical's ButterflyBVM single-use bag-valve-mask resuscitators, after the company found a higher-than-previously-observed rate of holes in the bellows, which can leak the air intended for the patient.

What is the clinical risk?

Inadequate ventilation and hypoxia during manual resuscitation, which FDA says could lead to serious injury or death if undetected.

Which lots are affected, and how?

Lots 000109 through 000117 are removed from use. Lots 000081 through 000108, including the ButterflyBVM PLUS, may stay in service only with a mandatory pre-use test before every patient use and a backup device on hand.

What should a clinician or facility do right now?

Run the pre-use test on in-service units before each patient use per the Instructions for Use; label any failed unit or removed-lot unit “DO NOT USE,” keep it in its packaging, and contact Compact Medical.

What is the device, and who makes it?

A single-use, three-in-one manual bag-valve-mask resuscitator from Compact Medical, Inc., FDA-cleared under 510(k) K243861 in April 2025, for patients from neonates through adults.