Recall Z-0478-2025— Caire, Inc.

Name: FDA recall Z-0478-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-04

Class II · Completed

Class II FDA medical device recall by Caire, Inc., initiated 2024-10-04. It names one FDA 510(k) clearance: K020324. Product: CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.. Reason: Potential failure of affected units to recharge the battery of the oxygen concentrators..

Recalling firm: Caire, Inc.
Classification: Class II
Status: Completed
Initiated: 2024-10-04
Firm location: Ball Ground, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K020324 — LIFESTYLE OXYGEN CONCENTRATORAirsep Corp.·cleared 2002-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.