Facility

FHC, INC.

3 recall(s) on record — most severe on record: Class I.

Key facts

3recalls · worst Class I

2inspections · 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)	3002250546
Establishment type	Manufacture Medical Device
Location	1201 MAIN ST Bowdoin, ME, US 04287
Registration status	Active · expires 2026
Parent company	FHC, Inc. (owner-operator 9037838)
Brand names	Visualase Stylet and accessories

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

Stylet, Surgical, General & Plastic Surgery
Product code GAH (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

Class IOngoing2024-10-04
A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product…
Class IITerminated2020-06-17
An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur.
Class IITerminated2018-05-10
The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove …

FDA inspections (2)

VAI2025-07-10
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-07-24
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.

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. “FHC, INC. (FEI 3002250546) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002250546-fhc-inc/

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