FDA Device recall Z-0248-2020
SAROS Oxygen System Model 3000
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of SAROS Oxygen System Model 3000 by Caire, citing there is an electronics control issue that causes the unit to not power on with battery power only.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0248-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-16 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Caire |
| Distribution | n/a |
Product
SAROS Oxygen System Model 3000
Reason
There is an electronics control issue that causes the unit to not power on with battery power only.
Identifiers
| code_info | Serial Numbers: CBB0817510005, CBB0817510003, CBB0817510004, CBB0817480515, CBB0817460330, CBB0818281053, CBB081751000…Serial Numbers: CBB0817510005, CBB0817510003, CBB0817510004, CBB0817480515, CBB0817460330, CBB0818281053, CBB0817510001, CBB0817510002, CBB0818330784, CBB0818281052 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0248-2020%22
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