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Stryker Sustainability Solutions: Daig Livewire Steerable, Product Number 401652; 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 401652; 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 00885825006983, Lot Numbers: 3430230, 4648604, 4945422, 4999751, 5044134, 5059493, 4454505, 4882788, 4950218, 4999755, 5044135, 5086419, 4454517, 4945388, 4993562, 5044132, 5044136, 5086420, 4648603, 4945405, 4993565, 5044133, 5044137.
Product quantity
24 units
Voluntary mandated
Voluntary: Firm initiated
City
Tempe
State
AZ
Country
United States
Event id
98708
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