BEUDAMED
    FDA Enforcement Class II Ongoing

    Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Recall: Z-2186-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2186-2026
    Event ID
    98708
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 20, 2026
    Initiation Date
    April 10, 2026
    Classification Date
    May 13, 2026
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327, United States

    Description

    Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Reason

    Incomplete seals on sterile product

    Code Info

    UDI 00885825006815, Lot Numbers: 2696145, 3794476, 4262195, 4633829, 4786916, 4849947, 5002352, 2965551, 3812493, 4265992, 4637189, 4792723, 4850691, 5002356, 3152561, 3814730, 4299204, 4637394, 4792893, 4851631, 5002359, 3172403, 3816485, 4337701, 4638269, 4793417, 4851632, 5002471, 3214127, 3851379, 4337958, 4639992, 4793418, 4851633, 5002472, 3229881, 3851380, 4345121, 4640104, 4794109, 4851635, 5008611, 3231417, 3851381, 4347049, 4640298, 4794112, 4862174, 5011458, 3312354, 3856993, 4352168, 4640299, 4794113, 4862621, 5017279, 3391553, 3859715, 4385951, 4644671, 4795044, 4865853, 5017489, 3419988, 3872508, 4395928, 4644672, 4795045, 4867603, 5027374, 3529291, 3895749, 4414258, 4645668, 4797291, 4867987, 5030307, 3535239, 3895751, 4419159, 4645812, 4797920, 4971117, 5031793, 3562006, 3895752, 4423479, 4647311, 4797924, 4971944, 5031878, 3582655, 3901375, 4425060, 4653274, 4797926, 4971947, 5032321, 3603300, 3918234, 4431614, 4664276, 4797930, 4971948, 5032386, 3636415, 3920888, 4437406, 4670462, 4799499, 4974025, 5034496, 3651834, 3937237, 4441090, 4670679, 4801581, 4979034, 5034497, 3655196, 3960672, 4458892, 4670680, 4807674, 4980507, 5034498, 3656249, 3970969, 4462985, 4672993, 4808182, 4980530, 5038587, 3658257, 3991875, 4473952, 4672995, 4808183, 4982050, 5038588, 3665444, 4012832, 4479589, 4672996, 4815394, 4984123, 5043499, 3677212, 4012885, 4481147, 4732567, 4815398, 4984126, 5043827, 3694515, 4071638, 4483708, 4732568, 4815399, 4984748, 5044555, 3709365, 4075854, 4486102, 4735809, 4816696, 4986997, 5044556, 3709396, 4088027, 4486103, 4735812, 4818303, 4986998, 5044557, 3710574, 4090987, 4497350, 4735814, 4818304, 4987268, 5044558, 3727131, 4095290, 4502986, 4735987, 4818306, 4987269, 5057014, 3728355, 4095510, 4502987, 4735988, 4818307, 4987270, 5080098, 3729486, 4097587, 4503631, 4735990, 4819692, 4992590, 5081266, 3747071, 4106743, 4523798, 4738428, 4819695, 4993071, 5081365, 3761145, 4108814, 4523801, 4740253, 4822574, 4993684, 5082367, 3763791, 4115879, 4533536, 4740739, 4826934, 4993689, 5082368, 3763855, 4119335, 4540396, 4741159, 4826935, 4993880, 5082369, 3763856, 4123513, 4549484, 4741160, 4826937, 4993881, 5082370, 3764216, 4149187, 4579089, 4744238, 4826938, 4993882, 5085317, 3770102, 4152148, 4597761, 4744239, 4828151, 4993883, 5085403, 3773860, 4175762, 4608379, 4745443, 4830359, 4993884, 5085404, 3774100, 4177955, 4608381, 4745445, 4833592, 4993885, 5085405, 3787685, 4178577, 4608382, 4749733, 4833593, 4998125, 5085406, 3790359, 4178582, 4610179, 4764854, 4834330, 4998610, 3794458, 4185882, 4613525, 4766335, 4834331, 4998611, 3794460, 4189493, 4615091, 4785653, 4834332, 4998612, 3794462, 4213206, 4624363, 4786265, 4840666, 4999415, 3794467, 4233873, 4630474, 4786266, 4845709, 5002341, 3794473, 4236800, 4631218, 4786915, 4849946, 5002349.

    Distribution

    US Nationwide and the countries of Israel and Canada.

    Quantity

    319 units