Medical device recalls Moderate risk

Liberty Medical Solutions, LLC recalls Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

Recall date
November 3, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0506-2024
FDA classification
Class II
Brand / firm
Liberty Medical Solutions, LLC
Sold / distributed
US Nationwide distribution in the states of CT, FL, NC, NJ, NY.

Why it was recalled

The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

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