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

Medical DevicesSource: FDA (device) · Date: 2026-09-23

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Stryker Sustainability Solutions
Product
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Reason / hazard
Reusable access port system may crack or seperate during use.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-08-19
Code info
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
Product quantity
2838 units
Voluntary mandated
Voluntary: Firm initiated
City
Tempe
State
AZ
Country
United States
Event id
99634
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