CLASS I Device recall · Reported 14 Dec 2022 · FDA Enforcement Report

Caire Liberator 45, Model 13261699, Liquid Oxygen System Unit recalled

Caire is recalling Caire Liberator 45, distributed nationwide in the US. The recall was initiated on 10 Oct 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI/DI M766132616990, Serial Numbers: CBB3022310887, CBB3022310888, CBB3022310852, CBB3022310823, CBB3022310792, CBB3022310843, CBB3022310844, CBB3022310827, CBB3022310842, CBB3022310845

Quantity recalled10 devices

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-0336-2023
FDA event ID: 90999
Recalling firm: Caire, Ball Ground, GA
Classification: Class I
Status: Terminated
Recall initiated: 10 Oct 2022
FDA classified: 2 Dec 2022
Reported: 14 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Oct 2022	Recall initiated by company
2 Dec 2022	Classified by FDA	+53 days
14 Dec 2022	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

An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.

Product as listed by the FDA

CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit

Where it was distributed

US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany

Nationwide Arizona California North Carolina Ohio

Questions about this recall

Is Caire Liberator 45, Model 13261699, Liquid Oxygen System Unit recalled?

Yes. Caire recalled Caire Liberator 45, Model 13261699, Liquid Oxygen System Unit on 10 Oct 2022. The recall is Class I and its status is Terminated. Recall number Z-0336-2023.

Why was it recalled?

An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.

Which lots are affected?

UDI/DI M766132616990, Serial Numbers: CBB3022310887, CBB3022310888, CBB3022310852, CBB3022310823, CBB3022310792, CBB3022310843, CBB3022310844, CBB3022310827, CBB3022310842, CBB3022310845

Where was it sold?

US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 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
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
27 Nov 2024Device	CLASS II	FreeStyle Comfort portable oxygen concentrator recalled by Caire	Caire	Device Malfunction	Nationwide
14 Dec 2022Device	CLASS I	Caire Liberator 30, Model 13337403, Liquid Oxygen System Unit recalled	Caire	Other	Nationwide

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