Baxter ventilator adaptor recalled for potential oxygenation failure and barotrauma risk
Baxter Healthcare is recalling in-line ventilator adaptors (Optimus Handset 2 module) used in home care. The devices may cause reduced oxygenation or barotrauma when used with Volara systems.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class I device involving serious potential hazards (reduced oxygenation, pneumothorax, barotrauma) in home care ventilator use. However, the source does not report any illnesses or injuries, and the hazard is described as potential rather than confirmed. Per the rubric, risk-of-harm products where injury has not yet been reported score High (3).
Plain-English summary
Baxter Healthcare Corporation is recalling in-line ventilator adaptors (code M07937 MODULE, Optimus Handset 2) manufactured from October 17, 2019 to present. The affected devices are distributed nationwide across multiple U.S. states.
The adaptors may cause reduced oxygenation or pneumothorax and barotrauma when used with the Volara system in home care environments. These risks were identified as potential hazards associated with the device's performance in in-line ventilator applications in home care settings.
Consumers and healthcare providers should be aware of this potential risk when using the affected devices.
The recalled product
- Product
- In-Line ventilator adaptor
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- reduced-oxygenation
- pneumothorax
- barotrauma
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 (4)
- M07937 MODULE
- OPTIMUS HANDSET 2
- UDI-DI: 00887761984622. Manufacturing dates October 17
- 2019 to present.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE Healthcare AW Server Radiological Image Processing System Software Defect
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Recalled for Breakage Risk
FDA (Devices) · 2026-07-01
- ModerateThuvera Laser Console Software Version 2.2 Recall Notice
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01