Safety recall
Medical
FDA
Is the Babytherm 8004/8010, Infant Warmer, Class II device,… safe?
Draeger Medical, Inc. · Recalled Jun 22, 2016
No — the Babytherm 8004/8010, Infant Warmer, Class II device,… was recalled on Jun 22, 2016 due to a safety issue. Recalled for a safety or quality concern — see details. If you have this product: Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Why it was recalled
Recalled for a safety or quality concern — see details.
What to do
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.
Babytherm 8004/8010, Infant Warmer, Class II device,…: common questions
Is the Babytherm 8004/8010, Infant Warmer, Class II device,… safe?
No. The Babytherm 8004/8010, Infant Warmer, Class II device,… was recalled on Jun 22, 2016 due to a safety issue. Recalled for a safety or quality concern — see details.
Has the Babytherm 8004/8010, Infant Warmer, Class II device,… been recalled?
Yes. The Babytherm 8004/8010, Infant Warmer, Class II device,… was recalled on Jun 22, 2016. The recall was issued by FDA (recall ID Z-2295-2016).
Why was the Babytherm 8004/8010, Infant Warmer, Class II device,… recalled?
Recalled for a safety or quality concern — see details.
What should I do if I have the Babytherm 8004/8010, Infant Warmer, Class II device,…?
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Where can I find the official recall notice for the Babytherm 8004/8010, Infant Warmer, Class II device,…?
The official FDA recall record is available
here. Always verify recall details with the official source.
TinySafe is an independent app and is not affiliated with, endorsed by, or sponsored by the FDA or CPSC. Always confirm recall details with the official source. The absence of a recall does not guarantee a product is safe.
