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Stryker Sustainability Solutions: Daig Livewire Steerable, Product Number 401581; 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 401581; 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 00885825006877, Lot Numbers: 3683857, 3836878, 3981321, 4042778, 4053585, 4103495, 4496897, 3683858, 3891551, 3991434, 4052721, 4053586, 4111212, 4496898, 3694871, 3932470, 3991439, 4052723, 4103479, 4111213, 4549309, 3762375, 3942462, 3991442, 4052726, 4103480, 4111214, 4549312, 3764605, 3964790, 3991444, 4052727, 4103481, 4111216, 4570926, 3764606, 3971860, 3991445, 4052735, 4103482, 4111218, 4570936, 3767575, 3973797, 4042769, 4052747, 4103483, 4111219, 4749790, 3767954, 3981001, 4042773, 4053579, 4103491, 4496884, 4753244, 3769052, 3981005, 4042776, 4053580, 4103492, 4496886, 4954168, 3808357, 3981320, 4042777, 4053582, 4103493, 4496892.
Product quantity
108 units
Voluntary mandated
Voluntary: Firm initiated
City
Tempe
State
AZ
Country
United States
Event id
98708
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