Facility

DORNIER MEDTECH AMERICA, INC.

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

Key facts

1recalls · worst Class II

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)	1037955
Establishment type	Manufacture Medical Device
Location	1155 ROBERTS BLVD. KENNESAW, GA, US 30144
Registration status	Active · expires 2026
Parent company	Dornier MedTech America, Inc. (owner-operator 1037955)
Brand names	Medilas H RFID Laser Fibers

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class IITerminated2019-04-01
Pin hole package failures compromising sterility of product

FDA inspections (1)

NAI2017-08-24
No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; 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 Dornier MedTech America, 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. “DORNIER MEDTECH AMERICA, INC. (FEI 1037955) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1037955-dornier-medtech-america-inc/

Not open yet

Alerts for DORNIER MEDTECH AMERICA, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.