Facility

TROKAMED GMBH

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

Key facts

1recalls · worst Class I

1inspections · 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)	3004595684
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	KLEINE BREITE 17 GEISINGEN Baden-Wurttemberg, DE 78187
Registration status	Active · expires 2026
Parent company	TROKAMED GMBH (owner-operator 9003550)
Brand names	Puncture Needle; Palpation Probe

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Laparoscope, General & Plastic Surgery
Product code GCJ (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

Class IOngoing2024-11-27
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

FDA inspections (1)

NAI2016-02-19
No 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 TROKAMED GMBH

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. “TROKAMED GMBH (FEI 3004595684) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004595684-trokamed-gmbh/

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