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Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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

U.S. FDA — Device Enforcement · United States · 2021-12-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0536-2022
Date of alert: 2021-12-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DIXI MEDICAL USA
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 03664539000053

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.