Recall Z-1637-2026— Baxter Healthcare Corporation
Class I · Ongoing
Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2026-02-18. It names 2 FDA 510(k) clearances: K200988, K192143. 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..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-02-18
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.