Volara ventilator adapter recalled as Class I over desaturation and barotrauma
Baxter is issuing an urgent correction for the Blue Ventilator Adapter Module used with the Volara system because home users may be unaware of possible oxygen desaturation or lung injury from overexpansion.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
The Blue Ventilator Adapter Module, single-patient use circuit, product code M07937, an accessory to the Baxter Volara Respiratory Therapy system, is being recalled. About 19 units were distributed in Florida.
This is an Urgent Medical Device Correction for the Volara system single-patient use circuit, issued because of 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. The correction provides the home caregiver with specific instructions for use. The FDA has classified this recall as Class I, its most serious category.
Affected product carries UDI/DI number 00887761984622.
Users and caregivers can identify affected circuits by the product code and UDI above, and may contact the recalling firm for further information.
The recalled product
- Product
- Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI/DI number 00887761984622
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- HighBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- HighBaxter Head Positioning Adapter May Loosen During Patient Positioning
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08
Same hazard · oxygen desaturation
See all →- SevereVentilator breathing circuit sets may obstruct exhalation valve
FDA (Devices) · 2026-07-08
- HighAirvo 3 Respiratory Device Recalled for Software Issue Affecting Oxygen Delivery
FDA (Devices) · 2024-10-02
- HighAirvo 2 and myAirvo 2 Humidifiers: Alarm Speaker Defect Recall
FDA (Devices) · 2024-05-22
- SevereNitric Oxide Delivery System check valve misalignment risk
FDA (Devices) · 2023-06-21
- SeverePhilips Respironics V60 Ventilator Flow Rate Reduction Safety Defect
FDA (Devices) · 2021-07-28