FDA Device recall Z-2186-2026

Daig Livewire Steerable, Product Number 401575

FDA Device
Class II
ongoing
Published 2026-05-20

On 2026-05-20 the FDA classified a Class II recall of Daig Livewire Steerable, Product Number 401575 by Stryker Sustainability Solutions, citing incomplete seals on sterile product.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2186-2026
Classification	Class II
Status	ongoing
Initiated	2026-04-10
Published	2026-05-20
Last updated	2026-09-13 11:58 UTC
Company	Stryker Sustainability Solutions
Distribution	US

Product

Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Reason

Incomplete seals on sterile product

Identifiers

code_info	UDI 00885825006815, Lot Numbers: 2696145, 3794476, 4262195, 4633829, 4786916, 4849947, 5002352, 2965551, 3812493, 4265… 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, 443

code_info

UDI 00885825006815, Lot Numbers: 2696145, 3794476, 4262195, 4633829, 4786916, 4849947, 5002352, 2965551, 3812493, 4265…

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, 443

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2186-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.