FDA (Devices) recall action 89306

DIXI MEDICAL USA recalled 9 products on 2022-02-09

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2022-02-09
Critical: 0
Units: 13,750

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

HighFDA (Devices)··2022-02-09
DIXI Medical Microdeep Depth Electrode Packaging Defect Threatens Sterile Barrier
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential packaging deformation that could compromise the sterile barrier. Approximately 2,720 units were distributed nationwide for use in brain recording and stimulation procedures.
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 va
Category
Distribution
0 states
HighFDA (Devices)··2022-02-09
DIXI Microdeep Depth Electrode packaging deformation poses sterility risk
DIXI Medical USA is recalling 2,141 Microdeep Depth Electrodes nationwide due to potential deformation of the blister pack that could compromise the sterile barrier when devices are removed from their Tyvek bags.
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 va
Category
Distribution
0 states
HighFDA (Devices)··2022-02-09
DIXI Medical Depth Electrodes recalled for potential sterile packaging defect
DIXI MEDICAL USA is recalling 461 Microdeep Depth Electrodes. The internal blister packaging may deform, potentially compromising the sterile barrier when removed from the protective Tyvek bag.
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 va
Category
Distribution
0 states
HighFDA (Devices)··2022-02-09
DIXI Microdeep Depth Electrode sterile barrier packaging defect
DIXI Medical Microdeep Depth Electrodes are recalled due to potential deformation of the blister pack packaging that could compromise the sterile barrier. 345 units nationwide are affected.
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 va
Category
Distribution
0 states
HighFDA (Devices)··2022-02-09
Microdeep Depth Brain Electrodes recall due to sterile barrier compromise risk
DIXI Medical is recalling 484 Microdeep Depth Electrodes nationwide due to potential deformation of internal packaging that could compromise the sterile barrier of these brain recording devices.
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 va
Category
Distribution
0 states
HighFDA (Devices)··2022-02-09
DIXI Microdeep Depth Electrodes recalled for potential packaging deformation compromising sterility
DIXI MEDICAL USA is recalling 1792 Microdeep Depth Electrodes due to potential deformation of the internal blister pack that could compromise the sterile barrier when the device is removed from its Tyvek bag.
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 va
Category
Distribution
0 states
HighFDA (Devices)··2022-02-09
FDA Recalls DIXI Medical Microdeep Depth Electrodes Due to Packaging Defect
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes nationwide due to potential internal packaging deformation that could compromise the device's sterile barrier.
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 va
Category
Distribution
0 states
HighFDA (Devices)··2022-02-09
DIXI Medical Microdeep Depth Electrode Sterile Barrier Compromise Recall
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes used in neurological monitoring and stimulation due to potential deformation of the internal sterile packaging. The compromised sterile barrier could allow contamination before use.
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 va
Category
Distribution
0 states
HighFDA (Devices)··2022-02-09
DIXI Medical Microdeep Depth Electrode packaging defect may compromise sterility
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential deformation of the internal packaging (blister pack) that could compromise the sterile barrier. The recall affects 365 units distributed nationwide.
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 va
Category
Distribution
0 states