Recall archive / FDA device enforcement
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 — FDA record Z-1117-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
- Reason
- The device was not cleared for U.S. distribution.
- Classification
- Class II
- Recalling firm
- Caire, Inc.
- Quantity
- 2 oxygen concentrators
- Agency-reported status
- Terminated
- Source record identifier
- Z-1117-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial numbers CBB5221200337 and CBB5221200287. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 25, 2022
- Recall initiation date
- Mar 25, 2022
- Center classification date
- May 19, 2022
- Termination date
- Oct 5, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.