FDA Device recall Z-1637-2026
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937
- FDA Device
- Class I
- ongoing
- Published 2026-04-08
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-1637-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-02-18 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Baxter Healthcare |
| Distribution | FL |
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_info | UDI/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.
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.