The Recall Desk

Manufacturer

Powers Medical Devices, LLC

1 recall in our database name Powers Medical Devices, LLC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2015-12-16

Of the 1 recalls from Powers Medical Devices, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-0395-2016·2015-12-16

    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.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide