Baxter Healthcare Corporation medical device recall: Blue Ventilator Adapter Module
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98458
- Recall initiated
- Feb 18, 2026
- Classified by FDA
- Apr 1, 2026
- Posted in Enforcement Report
- Apr 8, 2026
- Recalling firm
- Baxter Healthcare Corporation
- Firm location
- Deerfield, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 18, 2026. FDA classified it 42 days later, on Apr 1, 2026. Distribution reported by FDA: Florida Baxter Healthcare Corporation has 279 recalls in our records.
Recalled products (1)
Z-1637-2026 Class I Ongoing
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Codes / lots: UDI/DI number 00887761984622
Quantity: 19 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98458
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.