Facility

MILESTONE SCIENTIFIC, INC.

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

Key facts

1recalls · worst Class III

1inspections · 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)	3004082685
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	425 Eagle Rock Ave. Roseland, NJ, US 07068
Registration status	Active · expires 2026
Parent company	MILESTONE SCIENTIFIC, INC. (owner-operator 9026774)
Brand names	The CompuFlo Epidural Computer Controlled Anesthesia System

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Syringe, Piston
Product code FMF (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5860

Recalls & enforcement

Class IIITerminated2015-02-11
Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.

FDA inspections (1)

NAI2018-09-17
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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 MILESTONE SCIENTIFIC, 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. “MILESTONE SCIENTIFIC, INC. (FEI 3004082685) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004082685-milestone-scientific-inc/

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