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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89306

9 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 09, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DIXI MEDICAL USA

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

9 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 9

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.

Z-0534-2022
Recall number
Z-0534-2022
Initiated
December 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
DIXI MEDICAL USA
Quantity
484 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging (blister pack) could compromise sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All lots UDI: 03664539000015

Distribution pattern

US Nationwide distribution.

device · product 2 of 9

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.

Z-0535-2022
Recall number
Z-0535-2022
Initiated
December 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
DIXI MEDICAL USA
Quantity
1894 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging (blister pack) could compromise sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All lots UDI: 03664539000039

Distribution pattern

US Nationwide distribution.

device · product 3 of 9

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.

Z-0536-2022
Recall number
Z-0536-2022
Initiated
December 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
DIXI MEDICAL USA
Quantity
2141 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging (blister pack) could compromise sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All lots UDI: 03664539000053

Distribution pattern

US Nationwide distribution.

device · product 4 of 9

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.

Z-0537-2022
Recall number
Z-0537-2022
Initiated
December 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
DIXI MEDICAL USA
Quantity
2720 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging (blister pack) could compromise sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All lots UDI: 03664539000077

Distribution pattern

US Nationwide distribution.

device · product 5 of 9

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.

Z-0538-2022
Recall number
Z-0538-2022
Initiated
December 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
DIXI MEDICAL USA
Quantity
3548 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging (blister pack) could compromise sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All lots UDI:03664539000091

Distribution pattern

US Nationwide distribution.

device · product 6 of 9

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.

Z-0539-2022
Recall number
Z-0539-2022
Initiated
December 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
DIXI MEDICAL USA
Quantity
461 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging (blister pack) could compromise sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All lots UDI:03664539000152

Distribution pattern

US Nationwide distribution.

device · product 7 of 9

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.

Z-0540-2022
Recall number
Z-0540-2022
Initiated
December 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
DIXI MEDICAL USA
Quantity
345 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging (blister pack) could compromise sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All lots UDI:03664539000114

Distribution pattern

US Nationwide distribution.

device · product 8 of 9

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.

Z-0541-2022
Recall number
Z-0541-2022
Initiated
December 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
DIXI MEDICAL USA
Quantity
1792 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging (blister pack) could compromise sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All lots UDI:03664539000176

Distribution pattern

US Nationwide distribution.

device · product 9 of 9

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.

Z-0542-2022
Recall number
Z-0542-2022
Initiated
December 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
DIXI MEDICAL USA
Quantity
365 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging (blister pack) could compromise sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All lots UDI:03664539000138

Distribution pattern

US Nationwide distribution.