FDA recall Z-1600-2023

Product

Fisher Wallace Stimulator Models FW-100 and FW-200

Reason for recall

If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.

Distribution

US Nationwide. Global Distribution.

Key facts

Status

Ongoing

Initiation date

2023-04-06

Report date

2023-05-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brooklyn, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1600-2023