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Stryker Sustainability Solutions: Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Medical DevicesSource: FDA (device) · Date: 2026-05-20

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Stryker Sustainability Solutions
Product
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason / hazard
Incomplete seals on sterile product
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide and the countries of Israel and Canada.
Recall initiated
2026-04-10
Code info
UDI 00885825007270, Lot Numbers: 4026564, 4229299, 4801695, 4953879, 4987354, 5020148, 5075816, 4062382, 4229325, 4820358, 4953880, 4993906, 5034504, 5075889, 4126798, 4274291, 4821138, 4953881, 4993907, 5034505, 5075890, 4133063, 4294908, 4835292, 4953882, 4993909, 5044394, 5075900, 4159795, 4393599, 4841302, 4972396, 4993911, 5044402, 5075908, 4185728, 4487172, 4842791, 4972397, 4998472, 5047707, 4186431, 4550977, 4857135, 4972398, 4998473, 5053484, 4202027, 4574015, 4866297, 4972399, 4998474, 5058443, 4229211, 4584299, 4872587, 4972415, 5004432, 5063958, 4229292, 4594942, 4873162, 4987352, 5014723, 5066753, 4229294, 4737174, 4881443, 4987353, 5019469, 5066980.
Product quantity
107 units
Voluntary mandated
Voluntary: Firm initiated
City
Tempe
State
AZ
Country
United States
Event id
98708
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