CLASS I Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
Caire Liberator 45, Model 13262253, Liquid Oxygen System Unit recalled
Caire is recalling Caire Liberator 45, Model 13262253, Liquid Oxygen System Unit, 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
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-0337-2023
- 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
- 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 13262253, Liquid Oxygen System Unit
Where it was distributed
US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
Questions about this recall
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 M766132622530, Serial Numbers: CBB3022311044, CBB3022311042, CBB3022311043, CBB3022311040, CBB3022311242, CBB3022311098, CBB3022311093, CBB3022311094, CBB3022311077, CBB3022311053, CBB3022311049, CBB3022311065, CBB3022311051, CBB3022311075, CBB3022311078, CBB3022311097, CBB3022311096, CBB3022311079, CBB3022311045, CBB3022311046, CBB3022311236, CBB3022311230, CBB3022311217, CBB3022311231, CBB3022311164, CBB3022311225, CBB3022311226, CBB3022311133, CBB3022311192, CBB3022311163, CBB3022311216, CBB3022311228, CBB3022311227, CBB3022311162, CBB3022311198, CBB3022311211, CBB3022311202, CBB3022311155, CBB3022311135, CBB3022311171, CBB3022311121, CBB3022311106, CBB3022311109, CBB3022311108, CBB3022311084, CBB3022311083, CBB3022311092, CBB3022311081, CBB3022311082, CBB3022311141, CBB3022311131, CBB3022311136, CBB3022311183, CBB3022311178, CBB3022311130, CBB3022311179, CBB3022311139, CBB3022311177, CBB3022311105, CBB3022311146, CBB3022311172, CBB3022311140, CBB3022311125, CBB3022311169, CBB3022311068, CBB3022311176, CBB3022311170, CBB3022311180, CBB3022311057, CBB3022311129
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 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 90999| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Caire Liberator 20, Model 13256195, Liquid Oxygen System Unit recalled | Caire | Other | Nationwide | |
| CLASS I | Caire Liberator 30, Model 13337403, Liquid Oxygen System Unit recalled | Caire | Other | Nationwide | |
| CLASS I | Caire Liberator 45, Model 13261699, Liquid Oxygen System Unit recalled | Caire | Other | 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 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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