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Completed

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.

FDA Recall Z-0478-2025 · Posted 2024-11-15

Recalling FirmCaire, Inc.
Recall StatusCompleted
Product CodeCAW
Date Initiated2024-10-04
Product Quantity739 concentrators

Reason for Recall

Potential failure of affected units to recharge the battery of the oxygen concentrators.

Firm Action

The recalling firm issued letters via email on and dated 10/4/2024 to their "sold-to" DME (durable medical equipment) distributors. The letter explained the reason for recall, identified the affected serial numbers and when they were shipped to the DME distributor, and requested the devices be returned to the recalling firm immediately. They are informed the devices will be replaced with new or repaired units. The DME distributor is to contact the CAIRE Customer Service via phone or email to arrange for return of the devices. A Response Form: Acknowledgement of Receipt was enclosed to indicate they have read and understand the recall instructions.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020324LIFESTYLE OXYGEN CONCENTRATORAirsep Corp. · 2002-03-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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