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FDA (Device enforcement)Recalled 2026-04-10class ii

Stryker Sustainability Solutions: Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Hazard

Incomplete seals on sterile product

Details from the source

Reason for recall: Incomplete seals on sterile product Distribution: US Nationwide and the countries of Israel and Canada. Quantity: 1352 units Lot/code info: UDI 00885825007263, Lot Numbers: 3016810, 4488621, 4592565, 4801485, 4882673, 4967856, 4993019, 5004980, 5043929, 5071232, 3481897, 4488631, 4592566, 4802770, 4882750, 4967857, 4993023, 5005187, 5043930, 5071390, 3625879, 4488632, 4592567, 4804079, 4882752, 4967858, 4993039, 5005189, 5043931, 5071391, 3839101, 4488634, 4592569, 4807663, 4882753, 4968857, 4993040, 5005332, 5043932, 5071455, 3957393, 4488637, 4592570, 4807753, 4882754, 4968859, 4993322, 5005666, 5043985, 5071456, 3969685, 4488639, 4592571, 4807830, 4882758, 4968860, 4993327, 5005943, 5043986, 5071458, 3969688, 4488714, 4593641, 4808039, 4883012, 4968861, 4993563, 5005944, 5043988, 5071963, 3969689, 4488715, 4593648, 4808040, 4883125, 4968862, 4993564, 5008502, 5043990, 5071964, 3969691, 4488739, 4593688, 4808043, 4883516, 4968863, 4993567, 5009554, 5044183, 5071999, 3997894, 4488740, 4593691, 4808044, 4883867, 4969223, 4993568, 5009555, 5044426, 5072263, 4033681, 4488741, 4600193, 4808744, 4883868, 4971027, 4993570, 5011420, 5044427, 5072264, 4077276, 4488742, 4600447, 4808745, 4883869, 4971028, 4993663, 5011445, 5044428, 5073606, 4077953, 4488743, 4600448, 4808847, 4883873, 4971029, 4993665, 5011448, 5044452, 5074725, 4078768, 4489056, 4600449, 4809125, 4883874, 4971031, 4993667, 5012682, 5044492, 5074790, 4084962, 4489057, 4600450, 4809535, 4884126, 4971040, 4993668, 5012713, 5044493, 5074792, 4088602, 4490459, 4600471, 4810430, 4884403, 4971789, 4993688, 5012715, 5044559, 5074794, 4090290, 4492749, 4600568,

UPC codes

00885825007263

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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