Recall Z-3185-2026— Stryker Sustainability Solutions

Name: FDA recall Z-3185-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-19

Class II · Ongoing

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2026-08-19. It names one FDA 510(k) clearance: K201511. Product: REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM. Reason: Reusable access port system may crack or seperate during use..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Ongoing
Initiated: 2026-08-19
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K201511 — Reprocessed Endoscopic Trocars and SleevesStryker Sustainability Solutions·cleared 2020-07-31

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

REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM

Reason for recall

Reusable access port system may crack or seperate during use.

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