FDAHealthApril 10, 2026

Stryker Sustainability Solutions — Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

⚠️ Incomplete seals on sterile product

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 10, 2026

US Nationwide and the countries of Israel and Canada.

What's affected?

Product: Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Brand: Stryker Sustainability Solutions
Lot code: 3002664

Additional details

UDI 00885825006884, Lot Numbers: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, 4985861.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 19 units.

View original FDA notice →

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