Z-1600-2023 Class II Ongoing
FDA device recall Z-1600-2023 was initiated by Fisher Wallace Laboratories Inc. on Apr 6, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 43,489 total devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- Apr 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43,489 total devices
Product Description
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 Pattern
US Nationwide. Global Distribution.
Code Information
FW-100: UDI-DI 00860000919005, Serial Numbers 2020200000-2022278000; FW-200: UDI-DI 00860000919012, Serial Numbers 2021140129T-2022030528T
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1600-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026