Z-3183-2026 Class II Ongoing

Recalled by Stryker Sustainability Solutions — Tempe, AZ

FDA device recall Z-3183-2026 was initiated by Stryker Sustainability Solutions on August 19, 2026 and is designated Class II. Reason for recall: Reusable access port system may crack or seperate during use. The recall status is ongoing. Affected quantity: 2838 units.

Recall Details

Product Type
Devices
Report Date
September 23, 2026
Initiation Date
August 19, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2838 units

Product Description

REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM

Reason for Recall

Reusable access port system may crack or seperate during use.

Distribution Pattern

US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina , South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel and Canada.

Code Information

UDI: (01)00885825017231/ Lots: 16188647 16210212 16243934 16267300 16285639 16285656 16306188 16306231 16364978 16470903 16521533 16547722 16580202 16599810 16637989 16656930 16665550 17005619 17069758 17113276 17117460 17146892 17172722 17389157