Fisher Wallace Laboratories Inc.: Medical Device Recall in 2023 - (Recall #: Z-1600-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Fisher Wallace Stimulator Models FW-100 and FW-200

Product Classification:

Class II

Date Initiated: April 6, 2023

Date Posted: May 24, 2023

Recall Number: Z-1600-2023

Event ID: 91982

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.

Status: Ongoing

Product Quantity: 43,489 total devices

Code Information:

FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T

Distribution Pattern:

US Nationwide. Global Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated