Ball Ground, GA, United States
Caire, Inc. recalls
5 recalls recorded since 2018, most recently on 4 October 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)1
Completed Class II Medical devices
- Recall started
- 4 October 2024
- Reason
- Potential failure of affected units to recharge the battery of the oxygen concentrators.
- Distribution
- Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0481-2025, Z-0480-2025, Z-0478-2025, Z-0479-2025
- CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
- CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
- CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
- CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Terminated Class I Medical devices
- Recall started
- 10 October 2022
- Terminated
- 19 August 2024
- Reason
- 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
- US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0337-2023, Z-0339-2023, Z-0338-2023, Z-0336-2023
- CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
- CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
- CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
- CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
Terminated Class II Medical devices
- Recall started
- 25 March 2022
- Terminated
- 5 October 2023
- Reason
- The device was not cleared for U.S. distribution.
- Distribution
- Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1117-2022
- CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Terminated Class II Medical devices
- Recall started
- 21 November 2019
- Terminated
- 20 November 2020
- Reason
- Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
- Distribution
- US Nationwide distribution in the states of MI, CA, CT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0805-2020
- 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 doe
Terminated Class II Medical devices
- Recall started
- 16 September 2019
- Terminated
- 16 December 2020
- Reason
- There is an electronics control issue that causes the unit to not power on with battery power only.
- Distribution
- US and Chile
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0248-2020
- SAROS Oxygen System Model 3000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.