Caire, Inc.
Caire, Inc. holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2025, with 11 FDA device recalls on record.
Top product codes for Caire, Inc.
FDA recalls by Caire, Inc.
10 most recent of 11- Z-0478-2025 — CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
- Z-0480-2025 — CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
- Z-0479-2025 — CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
- Z-0481-2025 — CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
- Z-0337-2023 — CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
- Z-0339-2023 — CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
- Z-0338-2023 — CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
- Z-0336-2023 — CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
- Z-1117-2022 — CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
- 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 does it provide any patient monitoring capabilities.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Caire, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.