Facility

TECHNOMED ASIA, PT.

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

Key facts

3recalls · 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)	3008892509
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	K.I. Trikencana Kav. 4-5 Bandung Jawa Barat, ID 40921
Registration status	Active · expires 2026
Parent company	Technomed Europe (owner-operator 9036062)
Brand names	Lantern Laryngeal Electrode

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Stimulator, Nerve
Product code ETN (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.1820

Recalls & enforcement

Class IIOngoing2024-07-25
Product has have presence of brown discoloration or substance on the hinge area of the device
Class IITerminated2022-08-09
Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
Class IITerminated2021-12-08
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

FDA inspections (1)

NAI2016-05-25
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.

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. “TECHNOMED ASIA, PT. (FEI 3008892509) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008892509-technomed-asia-pt/

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