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

FDA device recall Z-1637-2026 · posted 2026-04-01 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

NHJ

Quantity affected

19 units

Distribution

Florida

Date initiated

2026-02-18

Date posted

2026-04-01

Location

Deerfield, IL

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