Baxter Healthcare Corporation recalls Blue Ventilator Adapter Module
- Recalling company
- Baxter Healthcare Corporation
- Product
- Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
- Reason
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Feb 18, 2026
- Reported
- Apr 8, 2026
- Distribution
- Florida
- Status
- Ongoing
- Quantity
- 19 units
- Lot / codes
- UDI/DI number 00887761984622
- Company location
- Deerfield, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1637-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1637-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.