Reported May 25, 2022 · Terminated

CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3

Caire, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Caire, Inc. · 2200 Airport Industrial Dr Ste 500 · Ball Ground, GA · 30107-4686

Is this the product you have?

  • CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Lot codes and dates
  • Serial numbers CBB5221200337 and CBB5221200287.
Amount recalled
2 oxygen concentrators

Where it was sold

Why it was recalled

The device was not cleared for U.S. distribution.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 5, 2023 · Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.