FDA recall Z-0506-2024

Product

Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

Reason for recall

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.

Distribution

US Nationwide distribution in the states of CT, FL, NC, NJ, NY.

Key facts

Status

Ongoing

Initiation date

2023-11-03

Report date

2023-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tampa, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2024