# FDA recall Z-0540-2022

> **DIXI MEDICAL USA** · Class II · device recall initiated 2021-12-09.

## Product

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.

## Reason for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0540-2022
- **Recalling firm:** DIXI MEDICAL USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-09
- **Report date:** 2022-02-09
- **Termination date:** 2023-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0540-2022

## Citation

> AI Analytics. FDA recall Z-0540-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0540-2022. Source: US FDA. Licensed CC0.

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