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FDAFDA · Food and drugs·Recall number Z-2188-2026

Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Published May 20, 2026 · Recall initiated: April 10, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Incomplete seals on sterile product

What to do

Voluntary: Firm initiated

Recall details

Manufacturer
Stryker Sustainability Solutions
Distributor
US Nationwide and the countries of Israel and Canada.
Lot
UDI 00885825006884, Lot Numbers: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, 4985861.
Risk classification
Class II
Area (FDA)
device
Country
United States

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