FDA Device recall Z-1600-2023
Fisher Wallace Stimulator Models FW-100 and FW-200
- FDA Device
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of Fisher Wallace Stimulator Models FW-100 and FW-200 by Fisher Wallace Laboratories, citing if the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1600-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-06 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fisher Wallace Laboratories |
| Distribution | US |
Product
Fisher Wallace Stimulator Models FW-100 and FW-200
Reason
If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.
Identifiers
| code_info | FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1600-2023%22
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