RecallRadar

FDA Device recall Z-1637-2026

Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937

On 2026-04-08 the FDA classified a Class I recall of Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937 by Baxter Healthcare, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1637-2026
ClassificationClass I
Statusongoing
Initiated2026-02-18
Published2026-04-08
Last updated2026-09-13 11:58 UTC
CompanyBaxter Healthcare
DistributionFL

Product

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

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.

Identifiers

code_infoUDI/DI number 00887761984622

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Other recalls by Baxter Healthcare

All Baxter Healthcare recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1637-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.