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

Recall Z-1619-2024 — 48" Lead Wires, Replacement Part Number: 1067724-4

U.S. FDA — Device Enforcement · United States · 2024-03-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1619-2024
Date of alert
2024-03-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
EBI, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00812301020324
Reported risk: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
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.

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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.