In-Line ventilator adaptor — Class I medical device recall Z-1138-2022
Terminated recall by Baxter Healthcare Corporation, reported 2022-06-08, distributed nationwide. There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used
| Recall number | Z-1138-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-04-26 |
| Classified | 2022-05-30 |
| Reported by FDA | 2022-06-08 |
| Terminated | 2024-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 259 units |
| UPC / GTIN / UDI-DI | 00887761981492 |
Product
In-Line ventilator adaptor
Reason for recall
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
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-1138-2022. 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.