RegWardenFDA facility compliance records
Facility

FISHER WALLACE LABORATORIES Inc

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2016: 1 inspections; 2019: 1 inspections; 2023: 1 recalls, 1 inspections; 2025: 1 inspections120162017201812019202020212022220232024120252026
  • Recalls (1)
  • Inspections (4)

Devices registered here (1)

  • Stimulator, Nerve, Transcutaneous, For Pain Relief
    Product code GZJ (opens in a new tab) · Class II · Neurology · 21 CFR 882.5890

Recalls & enforcement

  • Class IIOngoing2023-04-06
    If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.

FDA inspections (4)

  • VAI2025-05-13
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2023-03-15
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2019-06-25
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2016-03-01
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “FISHER WALLACE LABORATORIES Inc (FEI 3006258094) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006258094-fisher-wallace-laboratories-inc/

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