The Recall Desk

Manufacturer

Caire, Inc.

11 recalls in our database name Caire, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
4
Most recent
2024-11-27

Of the 11 recalls from Caire, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (36%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • HighFDA (Devices)·Z-0479-2025·2024-11-27

    CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Charging Failure

    CAIRE FreeStyle Comfort portable oxygen concentrators may fail to recharge their batteries, potentially leaving patients without access to supplemental oxygen. Twenty-three units have been recalled.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0481-2025·2024-11-27

    CAIRE FreeStyle Comfort portable oxygen concentrator battery recharge failure

    Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators due to potential battery recharge failure. Affected units identified by serial number may not charge properly.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0480-2025·2024-11-27

    CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Recharge Failure

    Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2025·2024-11-27

    CAIRE FreeStyle Comfort Oxygen Concentrators Recalled for Battery Charging Failure

    Caire recalls 739 FreeStyle Comfort portable oxygen concentrators that may fail to recharge their batteries. The devices were distributed in the US, Puerto Rico, Israel, and Peru.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0338-2023·2022-12-14

    FDA Class I Recall: CAIRE Liberator 30 Liquid Oxygen System Units

    Caire, Inc. is recalling five CAIRE Liberator 30 liquid oxygen system units due to weld defects on the inner bottle that could lead to device failure and loss of oxygen supply to dependent patients.

    Product
    CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2023·2022-12-14

    Caire Liberator 45 Liquid Oxygen System Recalled for Weld Defects

    Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units due to inconsistencies in weld penetration on the inner bottle discovered during an FDA audit.

    Product
    CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0337-2023·2022-12-14

    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.

    Product
    CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0339-2023·2022-12-14

    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.

    Product
    CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2022·2022-05-25

    Portable Oxygen Concentrator Recalled for Lack of FDA Clearance

    Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators because they were not cleared by the FDA for U.S. distribution. The affected devices were distributed to Puerto Rico.

    Product
    CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0805-2020·2020-01-22

    Caire FreeStyle Comfort Oxygen Concentrators Recalled for Lack of US Clearance

    Caire, Inc. is recalling four European version FreeStyle Comfort Oxygen Concentrators because they were not cleared for use in the US.

    Product
    CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0248-2020·2019-11-06

    Caire SAROS Oxygen System Model 3000 Recalled for Power Issue

    Caire, Inc. is recalling 10 SAROS Oxygen System Model 3000 units due to an electronics control issue that prevents the device from powering on with battery power only.

    Product
    SAROS Oxygen System Model 3000
    Category
    Medical Device
    Distribution
    0 states