CLASS II Device recall · Reported 22 Jan 2020 · FDA Enforcement Report
Caire Model: FreeStyle Comfort Oxygen Concentrator - Product Usage recalled
Caire is recalling Caire Model: FreeStyle Comfort Oxygen Concentrator - Product Usage, distributed nationwide in the US. The recall was initiated on 21 Nov 2019 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-0805-2020
- FDA event ID
- 84512
- Recalling firm
- Caire, Ball Ground, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Nov 2019
- FDA classified
- 13 Jan 2020
- Reported
- 22 Jan 2020
- 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
| 21 Nov 2019 | Recall initiated by company | |
| 13 Jan 2020 | Classified by FDA | +53 days |
| 22 Jan 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Product as listed by the FDA
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Where it was distributed
US Nationwide distribution in the states of MI, CA, CT.
Questions about this recall
Why was it recalled?
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Which lots are affected?
Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
Where was it sold?
US Nationwide distribution in the states of MI, CA, CT.
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.
More recalls from Caire
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FreeStyle Comfort portable oxygen concentrator recalled by Caire | Caire | Device Malfunction | Nationwide |
| Device | CLASS II | FreeStyle Comfort portable oxygen concentrator recalled by Caire | Caire | Device Malfunction | Nationwide |
| Device | CLASS II | FreeStyle Comfort portable oxygen concentrator recalled by Caire | Caire | Device Malfunction | Nationwide |
| Device | CLASS II | FreeStyle Comfort portable oxygen concentrator recalled by Caire | Caire | Device Malfunction | Nationwide |
| Device | CLASS I | Caire Liberator 45, Model 13261699, Liquid Oxygen System Unit recalled | Caire | Other | Nationwide |
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