Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT Recalled by Caire, Inc. Due to The device was not cleared for U.S. distribution.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Caire, Inc. directly.
Affected Products
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Quantity: 2 oxygen concentrators
Why Was This Recalled?
The device was not cleared for U.S. distribution.
Where Was This Sold?
Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
About Caire, Inc.
Caire, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report