Baxter Healthcare Corporation recalls Blue Ventilator Adapter Module

Urgent Medical Device Correction for the Volara system single-patient use circuit 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. This correction is providing the home caregiver specific instructions for use.

Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.

Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 2/18/2026 via email. The notice explained the issue, hazard involved, and requested the following: "Actions to be Taken by Customers 1. Continue your Volara therapy as prescribed by your doctor. 2. Refer to the enclosed IFU addendum for additional information related to use in the home care environment. The following warning was added for consideration related to this issue: Warning - Patients that may have difficulty clearing secretions from the upper airway may require specialized therapy (for example, separate suction unit) in addition to Volara therapy. Please consult your physician to determine if additional therapy is appropriate. 3. Monitor for signs of respiratory distress (increased breathing rate; wheezing; bluish color around the mouth, on the lips, or on the fingernails; changes in alertness; or drop in oxygen saturation level, etc.) during Volara therapy when used in-line with your ventilator. If signs of respiratory distress occur, stop the Volara therapy immediately. If you experience signs of respiratory distress and do not see improvement, please seek medical attention. 4. If you have questions or would like assistance with your Volara therapy in-line with a ventilator, please contact the Baxter Advanced Respiratory Clinical Support team at 800-397-9071, available 24 hours a day, 7 days a week. Clinical support can be provided via the phone, or Baxter can arrange for an in-person visit with a clinical patient trainer. 5. As part of the additional training, you will be asked to sign your confirmation of understanding of the training material and content of the IFU addendum." For general questions regarding this communication, please contact Baxter Advanced Respiratory Clinical Support team at 800-397-9071, available 24 hours a day, 7 days a week.

• FDA enforcement recordOfficial FDA database entry for Z-1637-2026
• FDA 510(k) clearance · K192143The device's official FDA premarket clearance record
• FDA 510(k) clearance · K200988The device's official FDA premarket clearance record
• FDA device classification · NHJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5905The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.