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Volara System recallZ-1637-2026 · Baxter Healthcare Corporation · initiated Feb 18, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1637-2026
Status
Open, Classified
Initiated by the company
Feb 18, 2026
Posted by the FDA
Apr 1, 2026
Recalling firm
Baxter Healthcare Corporation
Quantity
19 units
Product code
NHJ
FDA submissions
K192143, K200988
Distribution
Florida

Product description

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

Code information (models, lots, serial numbers)

UDI/DI number 00887761984622

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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