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

Lot, batch or date codesUDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790.

Quantity recalled23 concentrators

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-0479-2025
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 #AS200-101.

Where it was distributed

Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.

Nationwide Puerto Rico

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?

UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790.

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 95576

This 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
27 Nov 2024	CLASS II	FreeStyle Comfort portable oxygen concentrator recalled by Caire	Caire	Device Malfunction	Nationwide
27 Nov 2024	CLASS II	FreeStyle Comfort portable oxygen concentrator recalled by Caire	Caire	Device Malfunction	Nationwide
27 Nov 2024	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
27 Nov 2024Device	CLASS II	FreeStyle Comfort portable oxygen concentrator recalled by Caire	Caire	Device Malfunction	Nationwide
27 Nov 2024Device	CLASS II	FreeStyle Comfort portable oxygen concentrator recalled by Caire	Caire	Device Malfunction	Nationwide
27 Nov 2024Device	CLASS II	FreeStyle Comfort portable oxygen concentrator recalled by Caire	Caire	Device Malfunction	Nationwide
14 Dec 2022Device	CLASS I	Caire Liberator 45, Model 13261699, Liquid Oxygen System Unit recalled	Caire	Other	Nationwide
14 Dec 2022Device	CLASS I	Caire Liberator 30, Model 13337403, Liquid Oxygen System Unit recalled	Caire	Other	Nationwide

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2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide