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Recall Observatory FDA recall evidence

Device product

Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.

Z-1637-2026

February 18, 2026

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 98458
Status
Ongoing
Classification
Class I
Quantity
19 units
Official record key
device-enforcement:Z-1637-2026

Official wording

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.

Code information: UDI/DI number 00887761984622

Distribution pattern: Florida

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.