FDA recall, , High risk
Baxter Volara Ventilator Adapter Modules
The Blue Ventilator Adapter Module may cause unawareness of oxygen desaturation or barotrauma in home care.
Summary by Recall Canary from the FDA notice
What happened
Baxter Healthcare Corporation of Deerfield, Illinois, began an Urgent Medical Device Correction for the Blue Ventilator Adapter Module, a single-patient use circuit accessory to the Baxter Volara Respiratory Therapy system, on February 18, 2026.
The correction is due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment.
The FDA added the correction to its Enforcement Report on April 1, 2026, and it is in the weekly enforcement report on April 8, 2026, affecting 19 units in Florida.
What to do
If a code on your device is listed below:
- This correction is providing the home caregiver specific instructions for use.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
- UDI-DI
- 00887761984622
Recall details
- Company began the recall
- Sold in
- Company
- Baxter Healthcare CorporationDeerfield, Illinois
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98458
- Recall number
- Z-1637-2026
- Quantity recalled
- 19 units
All recalls from Baxter Healthcare Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
