FDA Devices recall · Reported December 14, 2022
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
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.
Caire, Inc. recalled CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit - a critical-severity action.
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit was recalled by Caire, Inc. in December 14, 2022. Reason: An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottl…. Check the official notice for the remedy. Verify recall #Z-0336-2023 with the FDA Devices before acting.
The recall
Caire, Inc. issued this critical-severity FDA Devices recall-An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottl….
- Critical
- severity level
- 10 units
- affected scope
- Class I
- classification
- December 14, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0336-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0336-2023) was formally reported on December 14, 2022, with the manufacturer initiating the action on October 10, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Caire, Inc. is listed as the recalling firm, operating out of Ball Ground, GA. Federal records list the affected scope as 10 devices.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0336-2023 |
| Date reported | December 14, 2022 |
| Date initiated | October 10, 2022 |
| Recalling firm | Caire, Inc. |
| Firm location | Ball Ground, GA |
| Affected scope | 10 devices |
| Distribution | US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0336-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026