Recall Z-0085-2027— Stryker Sustainability Solutions

Name: FDA recall Z-0085-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-18

Class II · Ongoing

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2026-08-18. It names one FDA 510(k) clearance: K030187. Product: BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007. Reason: Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Ongoing
Initiated: 2026-08-18
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K030187 — REPROCESSED ELECTROPHYSIOLOGY CATHETERAlliance Medical, Inc.·cleared 2003-09-24

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

BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007

Reason for recall

Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.

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