Facility

VISCOT MEDICAL LLC

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

Key facts

1recalls · worst Class III

3inspections · worst NAI

—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)	2242656
Establishment type	Repack or Relabel Medical Device
Location	5 Stewart Ct Denville, NJ, US 07834
Registration status	Active · expires 2026
Parent company	VISCOT MEDICAL LLC (owner-operator 9068829)

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Gauze/Sponge, Internal
Product code EFQ (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IIITerminated2012-08-22
Dual Tip Marker has inconsistent ink flow on the black permanent ink side.

FDA inspections (3)

NAI2025-03-03
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2022-04-20
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-02-27
No Action Indicated · Compliance: Devices

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 VISCOT MEDICAL LLC

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. “VISCOT MEDICAL LLC (FEI 2242656) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2242656-viscot-medical-llc/

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