CAIRE Inc.
5 recall(s) on record — most severe on record: Class I.
Recalls by year
- Recalls (5)
Registered facilities (3)
- CAIRE INC. FEI 3004972304 · GA
- CAIRE INC. FEI 2129616 · GA
- CAIRE Medical Technology (Chengdu) Co., Ltd. FEI 3009550619 · CN
Recalls & enforcement
- Class IICompleted2024-10-04Potential failure of affected units to recharge the battery of the oxygen concentrators.
- Class ITerminated2022-10-10An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
- Class IITerminated2022-03-25The device was not cleared for U.S. distribution.
- Class IITerminated2019-11-21Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
- Class IITerminated2019-09-16There is an electronics control issue that causes the unit to not power on with battery power only.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “CAIRE Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9008476-caire-inc/
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