PharmacovigilanceOfficial

FDA early alert: Compact Medical pulls ButterflyBVM resuscitator lots over bellows holes

🇺🇸 FDA MedWatch · Tue 03 Nov 2026

Compact Medical is removing nine ButterflyBVM lots and applying a pre-use test correction to 22 others after holes were found forming in the bellows.

The US Food and Drug Administration has issued an early alert, covering a potentially high-risk device issue, over Compact Medical's ButterflyBVM single-use bag-valve-mask resuscitators. The company has told customers to remove certain lots from use or sale and to apply updated instructions to others before they are used again.

Removal applies to lots 000109 to 000117 across the READY and standard A100 configurations. Correction applies to lots 000081 to 000108, covering READY, A100 and PLUS models. Compact Medical says lots 000109 to 000117 have shown a higher rate of bellows holes than previously observed.

Compact Medical first wrote to customers on 26 September 2026, warning that a hole could rarely develop in the bellows. A follow-up letter to all affected customers followed on 7 October 2026. A hole lets tidal volume escape instead of reaching the patient, which can cause inadequate ventilation and hypoxia and, if uncorrected, serious injury or death. As of 2 November 2026, the company had reported no serious injuries or deaths linked to the problem.

For removed lots, users should first put a replacement BVM in place, so no patient care area is left without a resuscitator. They should then check all locations, including vehicles, crash carts and storage, and label the units 'DO NOT USE'. Units are to be assumed affected if their packaging and labelling are missing. Distributors must stop distributing these lots. A 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 corrected lots, staff must run the Pre-Use Test / Equipment Check from the Instructions for Use before every patient use, and must not use any unit that fails. Backup BVMs should always be available. If ventilation looks inadequate, for example poor chest rise or falling oxygen saturation, staff should check for a hole in the back of the device. If one is found, they should switch to a backup unit immediately, then mark and quarantine the failed one. The FDA says it is still reviewing the issue and will update its page as significant new information emerges.

What it means for your team

  • Quality and supply teams should reconcile inventory against the affected lot numbers and UDI-DIs, including vehicles, kits, crash carts and storage, and confirm replacement stock before removing any units.
  • Clinical and risk teams should embed the pre-use test for the correction lots in practice and make sure backup BVMs are available in every patient care scenario.
  • Units that failed in use or are linked to patient harm must be preserved, not destroyed, and quarantined with their packaging pending instructions from Compact Medical.
  • Adverse events or quality problems can be reported to Compact Medical and to FDA MedWatch; distributors must halt distribution of lots 000109 to 000117.

Official source: FDA MedWatch ↗

Article written by VigiEye from the official source (FDA MedWatch). AI-assisted; check the source before acting.

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