Fisher Wallace Laboratories Inc.
FDA Regulatory Profile
Fisher Wallace Laboratories Inc. has 1 FDA recall, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1600-2023 · Class II · Apr 6, 2023
- Latest inspection
- May 13, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 7 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1600-2023 | Class II | Fisher Wallace Stimulator Models FW-100 and FW-200 | Apr 6, 2023 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| May 13, 2025 | Brooklyn, NY | Devices | Voluntary Action Indicated (VAI) | 3006258094 |
| Mar 15, 2023 | Brooklyn, NY | Devices | Voluntary Action Indicated (VAI) | 3006258094 |
| Jun 25, 2019 | Brooklyn, NY | Devices | No Action Indicated (NAI) | 3006258094 |
| Mar 1, 2016 | Brooklyn, NY | Devices | Voluntary Action Indicated (VAI) | 3006258094 |
| Jan 6, 2015 | Brooklyn, NY | Devices | No Action Indicated (NAI) | 3006258094 |
| Dec 20, 2012 | Brooklyn, NY | Devices | Voluntary Action Indicated (VAI) | 3006258094 |
| Jun 10, 2010 | Brooklyn, NY | Devices | Voluntary Action Indicated (VAI) | 3006258094 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3006258094 | Brooklyn, NY | 7 | May 13, 2025 |