Caire recalls four specific European model FreeStyle Comfort oxygen concentrators sold in the US that were not cleared for US use. These devices may not be safe for home use without proper medical clearance.
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Caire is recalling four specific European version FreeStyle Comfort oxygen concentrators sold in the US that were not cleared for US medical use. These devices could pose safety risks if used without proper medical clearance.
The recalled units were distributed in the US but were not cleared for medical use in the US. This means they may not meet US safety standards for oxygen therapy devices, potentially leading to unsafe operation or inadequate oxygen delivery.
Patients using oxygen therapy at home who own one of the four specific serial numbers listed are affected. Those with medical devices not cleared for US use face potential safety risks.
Check for the serial numbers: CBB5219310254, CBB5219310255, CBB5219310279, or CBB5219310280. These are the only four units distributed in the US that were not cleared for US use.
Look for the serial numbers: CBB5219310254, CBB5219310255, CBB5219310279, or CBB5219310280.
The four units were distributed in the US but were not cleared for medical use in the US, meaning they may not meet safety standards.
Check for the serial numbers: CBB5219310254, CBB5219310255, CBB5219310279, or CBB5219310280.
The recall record does not specify a remedy, so contact Caire directly for guidance.
We’ve drafted a message you can send Caire to request your refund or repair — edit it as you like.
Subject: Recall Z-0805-2020 — Caire Caire Hello, I own a Caire that is covered by recall Z-0805-2020 from Caire. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
