FDA Medical Device Recalls (openFDA)
Caire, Inc.: SAROS Oxygen System Model 3000
- Recall number
- Z-0248-2020
- Recalling firm
- Caire, Inc.
- Product
- SAROS Oxygen System Model 3000
- Status
- Terminated
- Initiated
- 2019-09-16
- Posted
- not on file
- Terminated
- 2020-12-16
- Reason
- There is an electronics control issue that causes the unit to not power on with battery power only.
- Root cause
- Nonconforming Material/Component
- Action
- The firm initiated the recall by email on 09/16/2019. The firm explained the issue and requested the return of the units.
- Quantity
- 10 units
- Distribution
- US and Chile
- Lot, serial or model codes
- Serial Numbers: CBB0817510005, CBB0817510003, CBB0817510004, CBB0817480515, CBB0817460330, CBB0818281053, CBB0817510001, CBB0817510002, CBB0818330784, CBB0818281052
- 510(k) numbers
- ["K083163"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 3004972304
- Firm city
- Ball Ground
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28