Quick Facts at a Glance
- Recall Date
- February 18, 2026
- Hazard Level
- HIGH
- Brand
- Baxter
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Baxter
- Product type
- Ventilator Adapter Module
- Model numbers
- UDI/DI number 00887761984622
- Colors
- Blue
- Sold at
- Unknown
- Where affected
- FL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 18, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions
About This Product
The Blue Ventilator Adapter Module is an accessory to the Baxter Volara Respiratory Therapy system used in home care to support ventilation therapy.
Why This Is Dangerous
The recall centers on the risk that users may not recognize a drop in oxygen levels or potential lung injury from overexpansion when using the Volara system at home.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects 19 units in Florida and requires immediate stop-use actions to reduce serious harm risk for home care patients.
Practical Guidance
How to identify if yours is affected
- Locate Blue Ventilator Adapter Module with Product Code M07937
- Verify it is part of Baxter Volara system and intended for single-patient use
- Check the UDI 00887761984622 on the device label
- If identified, stop using immediately and follow Baxter's instructions
Where to find product info
Device label should display Product Code M07937 and UDI 00887761984622
What timeline to expect
Baxter will provide recall remediation instructions; no refunds information is provided in the notice
If the manufacturer is unresponsive
- Document all communication attempts with Baxter
- File a report with the FDA or local health authorities if no response
- Consider consulting a lawyer if harm occurred
How to prevent similar issues
- Always verify product compatibility with the Volara system before use
- Monitor for recall notices from manufacturers and regulatory agencies
- Keep serial numbers and UDI numbers with medical device records
Documentation advice
Keep the recall notice, device labels, and UDI. Document dates of purchase and any communications with Baxter or providers. Photographs of the device and label are helpful.
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Product Details
Blue Ventilator Adapter Module; Product Code M07937; Accessory to Baxter Volara Respiratory Therapy system; Quantity: 19 units; Distribution: Florida; Sold at: Unknown; Date sold: Unknown; Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Code M07937
- Class I recall
- Stop-use-immediately; follow Baxter instructions
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