The Recall Desk
HighFDA (Devices)·Z-1139-2022·Announced 2022-06-08

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
Category
Medical Device — Respiratory equipment
Hazard
Affected units
9

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.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · reduced oxygenation

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