CLASS II Device recall · Reported 9 Feb 2022 · FDA Enforcement Report
The DIXI Medical Microdeep Depth Electrode recalled
Dixi Medical U is recalling The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ), distributed nationwide in the US. The recall was initiated on 9 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0539-2022
- FDA event ID
- 89306
- Recalling firm
- Dixi Medical U, Plymouth, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2021
- FDA classified
- 28 Jan 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 9 Dec 2021 | Recall initiated by company | |
| 28 Jan 2022 | Classified by FDA | +50 days |
| 9 Feb 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) recalled?
Yes. Dixi Medical U recalled The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) on 9 Dec 2021. The recall is Class II and its status is Terminated. Recall number Z-0539-2022.
Why was it recalled?
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Which lots are affected?
All lots UDI:03664539000152
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dixi Medical U
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The DIXI Medical Microdeep Depth Electrode recalled | Dixi Medical U | Sterility | Nationwide |
| Device | CLASS II | The DIXI Medical Microdeep Depth Electrode recalled | Dixi Medical U | Sterility | Nationwide |
| Device | CLASS II | The DIXI Medical Microdeep Depth Electrode recalled | Dixi Medical U | Sterility | Nationwide |
| Device | CLASS II | The DIXI Medical Microdeep Depth Electrode recalled | Dixi Medical U | Sterility | Nationwide |
| Device | CLASS II | The DIXI Medical Microdeep Depth Electrode recalled | Dixi Medical U | Sterility | Nationwide |
Other Patient Monitors recalls
All 1,012| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |
| Device | CLASS II | Digital ECG HD+12, HD+15 recalled by Midmark | Midmark | Labeling Errors | Nationwide |