DIXI Medical Microdeep Electrode Recall: Packaging Deformation Risk
DIXI Medical recalls Microdeep Depth Electrodes due to potential packaging deformation that could compromise sterile barrier. Affected units have UDI:0366453:000176. Stop using if packaging may be deformed.
Lower-risk recall
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Contact the company
What happened, in plain English
DIXI Medical is recalling Microdeep Depth Electrodes because the internal packaging might deform when removed from the Tyvek bag, risking a broken sterile barrier. This could lead to infection or contamination during medical use. The recall affects specific units with the UDI code 03664539000176. Read more at govinfonow.com/recall/61440-dixi-medical-microdeep-electrode-recall-packaging-deformation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61440-dixi-medical-microdeep-electrode-recall-packaging-deformation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0541-2022
Cite this page
“DIXI Medical Microdeep Electrode Recall: Packaging Deformation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61440-dixi-medical-microdeep-electrode-recall-packaging-deformation-risk. Based on FDA recall #Z-0541-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0541-2022%22&limit=1).
Why it’s dangerous
The electrode's internal packaging (blister pack) could deform when taken out of the Tyvek bag. This deformation might break the sterile barrier, increasing the risk of infection or contamination during medical procedures.
Who’s affected
Medical professionals using the electrode for brain signal monitoring or stimulation are most at risk. The recall applies to specific units with the UDI code 03664539000176.
How to tell if you have this one
Check for the UDI code 03664539000176 on the packaging. The product is a smooth electrode 0.8 mm in diameter used for brain signal monitoring.
- Brand
DIXI Medical- Category
Medical device
All 9 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0534-2022 | 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.; All lots UDI: 03664539000015 | 484 units |
| Z-0535-2022 | 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.; All lots UDI: 03664539000039 | 1894 units |
| Z-0536-2022 | 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.; All lots UDI: 03664539000053 | 2141 units |
| Z-0537-2022 | 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.; All lots UDI: 03664539000077 | 2720 units |
| Z-0538-2022 | 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.; All lots UDI:03664539000091 | 3548 units |
| Z-0539-2022 | 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.; All lots UDI:03664539000152 | 461 units |
| Z-0540-2022 | 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.; All lots UDI:03664539000114 | 345 units |
| Z-0541-2022 | 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.; All lots UDI:03664539000176 | 1792 units |
| Z-0542-2022 | 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.; All lots UDI:03664539000138 | 365 units |
What to do — step by step
Check Packaging Condition
Inspect the internal blister pack for signs of deformation before use.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0541-2022 (December 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0541-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.