Z-1637-2026Class I

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

Name: Z-1637-2026 Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara...
Creator: Baxter Healthcare Corporation
Published: 2026-02-18
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2026-02-18 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system on 2026-02-18. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1637-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-02-18
Posted: 2026-04-01
Recalling firm: Baxter Healthcare Corporation
Product: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Product code: NHJ Device, Positive Pressure Breathing, Intermittent
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 19 units
Distribution: Florida
Product codes and lots: UDI/DI number 00887761984622

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1637-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1637-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01

Product code NHJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)