Recall Z-2189-2026— Stryker Sustainability Solutions

Name: FDA recall Z-2189-2026
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 401603, 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 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Reason for recall

Incomplete seals on sterile product

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