Safety recall
Medical
FDA
Is the The "Pacifier Activated Lullaby" (PAL) System composed… safe?
Powers Medical Devices, LLC · Recalled Oct 01, 2015
No — the The "Pacifier Activated Lullaby" (PAL) System composed… was recalled on Oct 01, 2015 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.
The "Pacifier Activated Lullaby" (PAL) System composed…: common questions
Is the The "Pacifier Activated Lullaby" (PAL) System composed… safe?
No. The The "Pacifier Activated Lullaby" (PAL) System composed… was recalled on Oct 01, 2015 due to a safety issue. Recalled for a safety or quality concern — see details.
Has the The "Pacifier Activated Lullaby" (PAL) System composed… been recalled?
Yes. The The "Pacifier Activated Lullaby" (PAL) System composed… was recalled on Oct 01, 2015. The recall was issued by FDA (recall ID Z-0395-2016).
Why was the The "Pacifier Activated Lullaby" (PAL) System composed… recalled?
Recalled for a safety or quality concern — see details.
What should I do if I have the The "Pacifier Activated Lullaby" (PAL) System composed…?
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 The "Pacifier Activated Lullaby" (PAL) System composed…?
The official FDA recall record is available
here. Always verify recall details with the official source.
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