SAROS Oxygen System Model 3000 — Class II medical device recall Z-0248-2020
Terminated recall by Caire, Inc., reported 2019-11-06. There is an electronics control issue that causes the unit to not power on with battery power only.
| Recall number | Z-0248-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caire, Inc., Ball Ground, GA, United States |
| Recall initiated | 2019-09-16 |
| Classified | 2019-10-30 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-12-16 |
| Countries outside the US | CL |
| Quantity | 10 units |
| Serial numbers | CBB0817460330, CBB0817480515, CBB0817510001, CBB0817510002, CBB0817510003, CBB0817510004, CBB0817510005, CBB0818281052, CBB0818281053, CBB0818330784 |
| Model numbers | 3000 |
Product
SAROS Oxygen System Model 3000
Reason for recall
There is an electronics control issue that causes the unit to not power on with battery power only.
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-0248-2020. 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.