Fisher Wallace Laboratories Inc.: Fisher Wallace Stimulator Models FW-100 and FW-200

Hazard

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

Details from the source

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. Quantity: 43,489 total devices Lot/code info: FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T

UPC codes

00860000919005, 00860000919012

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.