CLASS II Device recall · Reported 25 May 2022 · FDA Enforcement Report
FreeStyle Comfort Portable Oxygen Concentrator with autoSAT recalled
Caire is recalling FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, distributed in Puerto Rico. The recall was initiated on 25 Mar 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1117-2022
- FDA event ID
- 90011
- Recalling firm
- Caire, Ball Ground, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2022
- FDA classified
- 19 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 25 Mar 2022 | Recall initiated by company | |
| 19 May 2022 | Classified by FDA | +55 days |
| 25 May 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device was not cleared for U.S. distribution.
Product as listed by the FDA
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Where it was distributed
Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
Questions about this recall
Why was it recalled?
The device was not cleared for U.S. distribution.
Which lots are affected?
Serial numbers CBB5221200337 and CBB5221200287.
Where was it sold?
Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | FreeStyle Comfort portable oxygen concentrator recalled by Caire | Caire | Device Malfunction | Nationwide |
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