Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The "Pacifier Activated Lullaby" (PAL) System composed of three major Recalled by Powers Medical Devices, LLC Due to PAL unit has undergone significant technological changes since...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Powers Medical Devices, LLC directly.
Affected Products
The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
Quantity: Total of 128 units
Why Was This Recalled?
PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Powers Medical Devices, LLC
Powers Medical Devices, LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report