The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0339-2023·Announced 2022-12-14

CAIRE Liberator 20 Liquid Oxygen System Recalled for Weld Defects

Caire, Inc. is recalling CAIRE Liberator 20 liquid oxygen system units due to weld penetration inconsistencies discovered during an FDA audit. The manufacturing defect affects 3 units.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric. The weld penetration defect affects device structural integrity. No reported injuries or deaths are mentioned in the source.

Plain-English summary

Caire, Inc. is recalling CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Units. This recall affects 3 units distributed across the United States and internationally.

An FDA audit discovered inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of some units. These weld defects could compromise the structural integrity of the device.

The affected units can be identified by their serial numbers: CBB3022320073, CBB3022320077, and CBB3022320074. Distribution included California, North Carolina, Ohio, and Arizona in the United States, as well as Canada, Chile, Colombia, and Germany internationally.

Consumers and healthcare providers with affected units should contact Caire, Inc. for instructions regarding the recalled devices.

The recalled product

Product
CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
Manufacturer
Caire, Inc.
Category
Medical Device — Oxygen Delivery System
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • UDI/DI M766133374030M766132561950
  • Serial Numbers: CBB3022320073
  • CBB3022320077
  • CBB3022320074

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Caire, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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