On November 2, 2026, the Food and Drug Administration (FDA) issued an Early Alert regarding a potential high-risk issue with ButterflyBVM Single-Use Bag-Valve-Mask Resuscitators. According to the FDA, Compact Medical has recommended the removal of certain lots of these devices and provided updated use instructions for others prior to continued use.

The alert follows reports that a hole may develop in the bellows of the devices, which could lead to inadequate ventilation and serious health risks. The FDA will provide updates as new information becomes available.

Press Release: Food and Drug Administration

Published November 2, 2026. Reproduced in full from the Food and Drug Administration.

Early Alert: Compact Medical Removes and Updates Use Instructions for ButterflyBVM Bag-Valve-Mask Resuscitators

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Compact Medical has issued an “Urgent Medical Device Recall” notice to affected customers recommending certain lots of ButterflyBVM Single-Use Bag-Valve-Mask (BVM) Resuscitators be removed from where they are used or sold. The notice also recommends updated use instructions (correction) for certain lots prior to continued use.

Affected devices:

Removal:

  • Product
  • SKU
  • UDI-DI
  • Lot Numbers
  • ButterflyBVM, READY
  • Each: R300
    Case: R308
  • Each: 00860012073528
    Case: 10860012073525
  • 000109, 000110,
    000111, 000112,
    000113, 000115,
    000116
  • ButterflyBVM, READY
  • Each: R300
    Case: R308
  • Each: 00860012073573
    Case: 00860012073580
  • 000117
  • ButterflyBVM
  • Each: A100
    Case: A108
  • Each: 00860012073504
    Case: 10860012073501
  • 000114

Correction:

  • Product
  • SKU
  • UDI-DI
  • Lot Numbers
  • ButterflyBVM, READY
  • Each: R300
    Case: R308
  • Each: 00860012073528
    Case: 10860012073525
  • 000081, 000083,
    000084, 000086,
    000093, 000094,
    000097, 000098,
    000099, 000100,
    000101, 000104,
    000107, 000108
  • ButterflyBVM
  • Each: A100
    Case: A108
  • Each: 00860012073504
    Case: 10860012073501
  • 000090, 000091,
    000096, 000105
  • ButterflyBVM, PLUS
  • Each: P200
    Case: P208
  • Each: 00860012073511
    Case: 10860012073518
  • 000089, 000092,
    000095, 000106

What to Do

Locate affected ButterflyBVM lots and determine whether they should be corrected or removed. For BVMs in patient care areas indicated for removal, stop using and remove affected devices as soon as a replacement BVM is in place. For BVMs indicated for correction, perform the Pre-Use Test before every use and do not use any unit that fails.

On September 26, 2026, Compact Medical sent a letter to customers notifying them that in rare situations, a hole may develop in the bellows of the ButterflyBVM. On October 7, 2026, Compact Medical sent all affected customers a follow-up letter on this issue and recommended the following actions:

Removal (Lots 000109 through 000117)

  • Make sure a replacement BVM is in place first. Before removing units from vehicles, carts, or kits, confirm each location has other bag-valve-masks available, so no patient care area is left without necessary resuscitators.
  • As soon as replacement BVMs are in place, stop using units within Lots 000109 - 000117. Do not use any ButterflyBVM from Lots 000109 through 000117.
  • If you no longer have a device’s packaging and labeling, assume that the device is included in the affected Lots.
  • Find and remove all units from within these Lots. Check all locations, including stations, vehicles, crash carts, and storage.
  • Quarantine and label. Separate units from within these Lots and label them “DO NOT USE” with a permanent marker.
  • Do not destroy any unit that failed while being used on a patient, or that is associated with a patient injury. If you have such a unit, mark it “DO NOT USE,” quarantine the unit with its original packaging, and contact [email protected] for more instructions.
  • Share this notice. Make sure all personnel who may use a ButterflyBVM know about this recall and correction.
  • Distributors: Stop distributing Lots 000109 through 000117.

Correction (Lots 000081 through 000108)

  • Check your inventory now. Identify every ButterflyBVM from Lots 000081 through 000108 at all locations, including stations, vehicles, crash carts, and storage.
  • Perform the Pre-Use Test / Equipment Check before every use. Immediately prior to using any ButterflyBVM unit within these Lots on a patient, perform the Pre-Use Test / Equipment Check as described in the section titled “Pre-Use Test / Equipment Check” of the Instructions for Use (IFU), available at www.butterflybvm.com/ifu.
  • Do not use any unit that fails. If a unit fails the Pre-Use Test / Equipment Check, do not use it for patient care. Label it “DO NOT USE,” set it aside with its original packaging, and contact Compact Medical at [email protected] for more instructions.
  • Always carry backup BVMs. Have backup bag-valve-masks available for every patient care scenario in case the ButterflyBVM fails the Pre-Use Test / Equipment Check.
  • Confirm no leak if ventilation seems inadequate. If during use you notice poor chest rise or falling oxygen saturation, ensure there is not a hole in the back of the device. If there is no hole, then perform the typical adjustments to tidal volume and peak inspiratory pressure that you would normally perform to improve ventilation. However, if you do detect a hole in the back of the device, change to a backup BVM right away and then follow the steps outlined above to mark and quarantine the unit and then contact Compact Medical for additional instructions.
  • Share this notice. Make sure all personnel who may use a ButterflyBVM know about this recall and correction.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Compact Medical has reported the potential for a hole to form in the bellows of certain ButterflyBVM devices. Units from Lots 000109 through 000117 have a higher rate of holes in the bellows than previously observed.

If a hole develops in the bellows, tidal volume can leak from the device instead of reaching the patient. A leak in the bellows can cause inadequate ventilation and hypoxia. If not corrected, this could result in serious injury or death.

As of November 2, 2026, Compact Medical has reported no serious injuries or deaths associated with this issue.

Device Use

ButterflyBVM is a Bag-Valve-Mask Resuscitator used for manual pulmonary resuscitation and emergency respiratory support.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Compact Medical at [email protected].

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.