Facility

FISHER WALLACE LABORATORIES Inc

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

Key facts

1recalls · worst Class II

4inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006258094
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	630 Flushing Avenue Brooklyn, NY, US 11206
Registration status	Active · expires 2026
Parent company	FISHER-WALLACE LABORATORIES Inc (owner-operator 9100824)

Activity by year

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.

All facilities operated by FISHER-WALLACE LABORATORIES Inc

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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