Recall Z-2191-2026— Stryker Sustainability Solutions

Name: FDA recall Z-2191-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-10

Class II · Ongoing

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2026-04-10. It names 4 FDA 510(k) clearances: K100254, K052603, K030187 and 1 more. Product: Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER. Reason: Incomplete seals on sterile product.

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Ongoing
Initiated: 2026-04-10
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

4 on FDA's record

K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERAscent Healthcare Solutions·cleared 2010-05-28
K052603 — REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERSAlliance Medical Corp.·cleared 2005-11-16
K030187 — REPROCESSED ELECTROPHYSIOLOGY CATHETERAlliance Medical, Inc.·cleared 2003-09-24
K012708 — ELECTROPHYSIOLOGY CATHETERAlliance Medical Corp.·cleared 2002-08-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Reason for recall

Incomplete seals on sterile product

Data sourced from openFDA. This site is unofficial and independent of the FDA.