Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Recalled by DIXI MEDICAL USA Due to Potential deformation of the internal packaging (blister pack)...

Date: December 9, 2021
Company: DIXI MEDICAL USA
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DIXI MEDICAL USA directly.

Affected Products

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

Quantity: 1894 units

Why Was This Recalled?

Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About DIXI MEDICAL USA

DIXI MEDICAL USA has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report