—#218810

Product

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

FDA product code: NHJ — Device, Positive Pressure Breathing, Intermittent
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K192143, K200988
Affected lot / code info: UDI/DI number 00887761984622

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Florida

Timeline

Recall initiated: 2026-02-18
Posted by FDA: 2026-04-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218810. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.