Caire, Inc. 2022-05-25 Health serious FDA
Health · FDA · Recall #FDA-Z-1117-2022
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and… Recall
Issued May 25, 2022 · Caire, Inc.
In May 2022, Caire, Inc. recalled the CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The device was not cleared for U.S. distribution.
What you should do
- 1 Stop using CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Caire, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Caire, Inc.
- Category
- Health
- Recall date
- May 25, 2022
- Units affected
- Not reported
- Sold at
- Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
- Recall number
- FDA-Z-1117-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Caire, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.