CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT — Class II medical device recall Z-1117-2022
Terminated recall by Caire, Inc., reported 2022-05-25, distributed in PR. The device was not cleared for U.S. distribution.
| Recall number | Z-1117-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caire, Inc., Ball Ground, GA, United States |
| Recall initiated | 2022-03-25 |
| Classified | 2022-05-19 |
| Reported by FDA | 2022-05-25 |
| Terminated | 2023-10-05 |
| Distributed | PR |
| Quantity | 2 oxygen |
| Reason classes | unapproved product |
| Serial numbers | CBB5221200287, CBB5221200337 |
| Model numbers | AS200-3 |
Product
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Reason for recall
The device was not cleared for U.S. distribution.
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-1117-2022. 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.