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

Class II
Recalling firm
Stryker Sustainability Solutions
Reason for recall
Reusable access port system may crack or seperate during use.
Affected products (lot / model / serial)
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
Units affected
2838 units
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.
Firm location
Tempe, AZ, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
N/A
Product type
Devices
Status
Ongoing
Recall number
Z-3183-2026
Recall initiated
August 19, 2026
FDA classification date
September 16, 2026
FDA report date
September 23, 2026
FDA event ID
99634
Last updated on HTM Vibe
September 29, 2026
View on openFDA