RegWardenFDA facility compliance records
Company

Technomed Europe

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

Recalls by year

FDA actions on record by year2021: 1 recalls; 2022: 1 recalls; 2024: 1 recalls2017201820192020120211202220231202420252026
  • Recalls (3)

Registered facilities (2)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Technomed Europe — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9036062-technomed-europe/

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