CLASS II Device recall · Reported 27 Nov 2024 · FDA Enforcement Report
FreeStyle Comfort portable oxygen concentrator recalled by Caire
Caire is recalling FreeStyle Comfort portable oxygen concentrator, distributed nationwide in the US. The recall was initiated on 4 Oct 2024 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-0480-2025
- FDA event ID
- 95576
- Recalling firm
- Caire, Ball Ground, GA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 4 Oct 2024
- FDA classified
- 15 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 4 Oct 2024 | Recall initiated by company | |
| 15 Nov 2024 | Classified by FDA | +42 days |
| 27 Nov 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
Where it was distributed
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Questions about this recall
Why was it recalled?
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Which lots are affected?
No UDI-DI (for export only); Serial numbers CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582.
Where was it sold?
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
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.
Other products in this recall event
3 other products · FDA event 95576This product is part of a recall event; the main page for the event is FreeStyle Comfort portable oxygen concentrator recalled by Caire.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | FreeStyle Comfort portable oxygen concentrator recalled by Caire | Caire | Device Malfunction | Nationwide | |
| CLASS II | FreeStyle Comfort portable oxygen concentrator recalled by Caire | Caire | Device Malfunction | Nationwide | |
| CLASS II | FreeStyle Comfort portable oxygen concentrator recalled by Caire | Caire | Device Malfunction | Nationwide |
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 I | Caire Liberator 45, Model 13261699, Liquid Oxygen System Unit recalled | Caire | Other | Nationwide |
| Device | CLASS I | Caire Liberator 30, Model 13337403, Liquid Oxygen System Unit recalled | Caire | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |