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The FDA issued an Early Alert about Compact Medical’s recall and correction of certain ButterflyBVM bag-valve-mask resuscitators. Lots 000109 through 000117 should be removed once replacements are available; lots 000081 through 000108 require a pre-use test before every use. As of November 2, 2026, the company had reported no serious injuries or deaths associated with the issue.
The U.S. Food and Drug Administration has issued an Early Alert about Compact Medical’s ButterflyBVM bag-valve-mask resuscitators, after the company reported that holes may develop in the bellows of certain units. The alert directs users to remove lots 000109 through 000117 once replacement devices are in place, and to test lots 000081 through 000108 before every use.
The FDA’s Center for Devices and Radiological Health said Compact Medical issued an urgent medical device recall notice to affected customers. The notice divides the affected devices into two groups: units that should be removed from service and units that may remain in use only with added checks. The recommendations apply to specified lots of the ButterflyBVM, ButterflyBVM READY and ButterflyBVM PLUS, depending on the product and lot.
For lots 000109–000117, Compact Medical recommends stopping use and removing the devices after a replacement bag-valve-mask is available. The company tells users to check patient-care areas, vehicles, carts, kits and storage, and to avoid leaving a location without a resuscitator. Affected units should be separated and marked “DO NOT USE.” Distributors are advised to stop distributing the listed lots. If packaging is unavailable, the company says to assume the device is from an affected lot.
For lots 000081–000108, the company’s correction calls for a Pre-Use Test or Equipment Check immediately before every use. Units that fail should not be used for patient care; users should mark and set them aside and contact Compact Medical. The instructions also call for backup BVMs to be available. If ventilation appears inadequate, users are told to check for a hole in the back of the device; if one is found, switch to a backup BVM.
Risks During Manual Ventilation
A bag-valve-mask provides manual ventilation when a patient needs breathing support. The FDA says a hole in the bellows could allow air volume to leak rather than reach the patient, potentially causing inadequate ventilation and hypoxia. The agency warns that, if the problem is not addressed, it could lead to serious injury or death.
The two-part action reflects different instructions for the identified lots: some are to be removed, while others require a check before each use. For emergency services and clinical teams, the removal instruction includes a practical safeguard: put a replacement in place first so a station, vehicle or care area is not left without necessary resuscitation equipment. The FDA has described the issue as potentially high-risk, but the supplied alert does not say that every device in the listed lots has a defect.
The company’s reported status is also relevant to interpreting the alert. The FDA said that, as of November 2, 2026, Compact Medical had reported no serious injuries or deaths associated with the issue. That report does not establish that the risk is absent; it is a time-specific update from the company conveyed by the FDA.
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How the Recall Is Divided
The FDA says Compact Medical notified customers in a letter dated September 26, 2026, stating that a hole could form in the bellows in rare situations. A follow-up letter sent to affected customers on October 7 outlined the removal and correction actions. The FDA then issued its Early Alert to notify the public of the potentially high-risk device issue and said it was reviewing information about it.
The affected products are single-use bag-valve-mask resuscitators, devices used to provide manual pulmonary resuscitation. The FDA’s alert lists product names, SKUs, UDI-DI identifiers and lot numbers to help users distinguish removal lots from correction lots. The removal group is lots 000109–000117; the correction group is lots 000081–000108, across the listed ButterflyBVM product configurations.
Compact Medical’s instructions are operational as well as product-specific: users are asked to identify units across all storage and response locations, share the notice with personnel who may use the devices, and contact the company about failed units. The FDA says it will update its alert page as significant new information becomes available.
“The company reported that “in rare situations, a hole may develop in the bellows of the ButterflyBVM.””
— Compact Medical, as described in the FDA alert
Extent of the Device Problem
The alert does not state how many devices were distributed or remain in use, how many units have developed holes, or how many customers have completed the recommended actions. It also does not provide a confirmed cause for the bellows holes or a timetable for resolving the issue.
The FDA says Compact Medical reported a higher rate of holes in lots 000109–000117 than previously observed, but the alert supplies no rate, comparison period or number of affected devices. That statement should not be read as a quantified estimate of the likelihood that any particular unit will fail. The agency says it is reviewing information, so the scope and assessment may change as further details become available.
As of November 2, the company had reported no serious injuries or deaths associated with the issue. The alert does not say whether there were less serious incidents or device failures, and it does not provide additional outcome data. Users should follow the lot-specific directions rather than assume that an unreported event means a device is free of risk.
Checks and FDA Updates
Facilities, emergency responders and distributors should identify the listed lots and apply the appropriate action: remove lots 000109–000117 after replacements are in place, and perform the pre-use check on lots 000081–000108 before each use. Failed devices should be kept out of patient care, marked and quarantined; Compact Medical asks users to contact it for instructions. The company also advises keeping backup BVMs available and sharing its notice with all personnel who may use the devices.
The FDA says it is reviewing information and will update its Early Alert page when significant new information becomes available. The supplied alert does not give a date for another update or say when the company’s actions will be complete. Users should check the FDA notice and Compact Medical’s instructions for current information.
Key Questions
Which ButterflyBVM lots should be removed?
The FDA alert identifies lots 000109 through 000117 for removal. Compact Medical says to put a replacement BVM in place before taking a unit out of a patient-care area, then mark the affected device “DO NOT USE.”
Can lots 000081 through 000108 still be used?
The company’s correction says units in lots 000081 through 000108 require a Pre-Use Test or Equipment Check immediately before each use. Do not use a unit that fails, and keep backup BVMs available.
What problem did Compact Medical report?
Compact Medical reported that a hole may develop in the bellows of certain devices. The FDA says a leak could reduce the ventilation delivered to a patient and lead to inadequate ventilation and hypoxia.
Have serious injuries or deaths been reported?
According to the FDA alert, as of November 2, 2026, Compact Medical had reported no serious injuries or deaths associated with this issue. The alert does not provide further information about other reported events.
Source: fda.gov
