Class II

Medical Device Recall: CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.

Caire, Inc. · October 4, 2024

Reason for Recall

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.

States Affected

NATIONWIDE

Quantity Affected

23 concentrators

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0479-2025

Status: completed

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Caire, Inc. Medical Device Recall: CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. | SafeCheck