The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0337-2023·Announced 2022-12-14

Liquid Oxygen System Devices Recalled Due to Weld Quality Issues

Caire Inc. is recalling 70 CAIRE Liberator 45 liquid oxygen systems due to inconsistencies in weld penetration on the inner bottle's longitudinal weld seam discovered during an audit.

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 establishes a minimum severity score of Severe (score 4). No deaths, serious injuries, or hospitalizations are reported in the source material. The classification remains Severe based on the Class I designation.

Plain-English summary

CAIRE Inc. is recalling 70 units of the CAIRE Liberator 45 liquid oxygen system (Model 13262253) due to weld defects discovered during an audit.

An audit identified inconsistencies in weld penetration on the longitudinal weld seam of the inner bottle affecting some units. The defect involves the structural weld seam of the device's inner bottle.

The affected units were distributed to California, North Carolina, Ohio, Arizona, and internationally to Canada, Chile, Colombia, and Germany. Specific serial numbers are provided in the FDA's recall notice. This recall was classified as Class I by the FDA.

The recalled product

Product
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
Manufacturer
Caire, Inc.
Category
Medical Device — Oxygen Delivery System
Hazard
Affected units
70

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 (20)

  • UDI/DI M766132622530
  • Serial Numbers: CBB3022311044
  • CBB3022311042
  • CBB3022311043
  • CBB3022311040
  • CBB3022311242
  • CBB3022311098
  • CBB3022311093
  • CBB3022311094
  • CBB3022311077
  • CBB3022311053
  • CBB3022311049
  • CBB3022311065
  • CBB3022311051
  • CBB3022311075
  • CBB3022311078
  • CBB3022311097
  • CBB3022311096
  • CBB3022311079
  • CBB3022311045

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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