Fisher Wallace Stimulator Models FW-100 and FW-200 — Class II medical device recall Z-1600-2023
Ongoing recall by Fisher Wallace Laboratories Inc., reported 2023-05-24, distributed nationwide. If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, ir
| Recall number | Z-1600-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fisher Wallace Laboratories Inc., Brooklyn, NY, United States |
| Recall initiated | 2023-04-06 |
| Classified | 2023-05-17 |
| Reported by FDA | 2023-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 43,489 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00860000919005, 00860000919012 |
| Serial numbers | 2020200000-2022278000, 2021140129T-2022030528T, FW-200 |
| Model numbers | FW-100, FW-200 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1600-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.