Blue Ventilator Adapter Module — Class I medical device recall Z-1637-2026
Ongoing recall by Baxter Healthcare Corporation, reported 2026-04-08, distributed in FL. Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that pa
| Recall number | Z-1637-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2026-02-18 |
| Classified | 2026-04-01 |
| Reported by FDA | 2026-04-08 |
| Distributed | FL |
| Quantity | 19 units |
| UPC / GTIN / UDI-DI | 00887761984622 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1637-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.