Powers Medical Devices Recalls Pacifier Activated Lullaby Systems for Labeling Issues
Powers Medical Devices is recalling 128 Pacifier Activated Lullaby (PAL) Systems because the units' labeling is inconsistent with their FDA-cleared indications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a labeling inconsistency rather than a physical defect causing injury. This aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Powers Medical Devices, LLC is recalling 128 units of the "Pacifier Activated Lullaby" (PAL) System. The PAL System is a medical device designed to encourage and reinforce effective non-nutritive sucking in premature infants. The system consists of a Player Module, a Pacifier Sensor, and a power supply.
The recall was initiated because the PAL units have undergone significant technological changes since the previous 510(k) clearance. Consequently, the product labeling is not consistent with the cleared indications of the 510(k). The affected units were distributed nationwide between November 2012 and July 2015.
Consumers and healthcare facilities should check their inventory for PAL Systems with the specific serial numbers listed in the official recall notice. If a unit is found, it should be removed from service and returned to Powers Medical Devices, LLC in accordance with their instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Powers Medical Devices, LLC
- Category
- Medical Device — Neonatal Care
- Hazard
- Affected units
- 128
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers A1221
- A1226 (Ship Date 07/2015)
- Serial Numbers A1061
- A1250
- A1251 (Ship Date 05/2015)
- Serial Number A1246 (Ship Date 04/2015)
- Serial Numbers A1245
- A1244
- A1042
- A1243 (Ship Date 02/2015)
- Serial Number A1225 (Ship Date 01/2015)
- Serial Numbers A1241
- A1242 (Ship Date 12/2014)
- Serial Number A1036 (Ship Date 11/2014)
- Serial Numbers A1229
- A1247
- A1224 (Ship Date 10/2014)
- Serial Numbers A1239
- A1234
- A1236
Distribution
Distributed nationwide across the United States.
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