FDA Early Alert: ButterflyBVM Resuscitator Bellows May Tear and Leak, With 9 Lots Removed and 22 Lots Under Updated Instructions
The U.S. Food and Drug Administration (FDA) issued an early alert on November 3: the bellows of the ButterflyBVM disposable bag valve mask resuscitators made by Compact Medical can develop holes, leaking the delivered tidal volume and leaving patients under-ventilated or hypoxic, with a risk of serious injury or death. Emergency and clinical staff who use these resuscitators should check lot numbers and follow the instructions below.
Nine lots (000109 through 000117) are being removed: the READY models (SKUs R300 and R308) account for most of them, with lot 000117 listed under its own unique device identifier (UDI), and the standard models (A100 and A108) are in lot 000114. The FDA says facilities should secure a replacement resuscitator before taking removed lots out of service, quarantine them, and mark them "DO NOT USE"; distributors should stop shipping lots 000109 through 000117.
Another 22 lots (000081 through 000108) carry updated instructions: 14 READY lots, four standard lots and four PLUS lots (P200 and P208). For these, a pre-use test must be performed before every use, any unit that fails must not be used, and a backup bag valve mask should always be kept on hand.
Compact Medical wrote to customers about the issue on September 26 and October 7, 2026. The FDA said that as of November 2, 2026, it had received no reports of serious injuries or deaths associated with the problem.
Questions can go to the company at [email protected], and adverse events can be reported to the FDA's MedWatch program.
(Source: U.S. Food and Drug Administration)
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 球囊面罩复苏器（资料图，与涉事产品同类）。Hospital 摄，CC BY-SA 3.0，经 Wikimedia Commons。 / A bag valve mask resuscitator (file photo, same type of device as the affected product). Photo by Hospital, CC BY-SA 3.0, via Wikimedia Commons.
