The DIXI Medical Microdeep Depth Electrode — Class II medical device recall Z-0535-2022
Terminated recall by DIXI MEDICAL USA, reported 2022-02-09, distributed nationwide. Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device
| Recall number | Z-0535-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DIXI MEDICAL USA, Plymouth, MI, United States |
| Recall initiated | 2021-12-09 |
| Classified | 2022-01-28 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2023-09-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,894 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 03664539000039 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0535-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.