Device recall
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
- Recall number
- Z-3183-2026
- Event id
- 99634
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Stryker Sustainability Solutions
- Report date
- Sep 23, 2026
- Posted
- Sep 16, 2026
- Initiated
- Aug 19, 2026
- Center classification date
- Sep 16, 2026
- Product code
- NLM
- Device type
- Laparoscope, General & Plastic Surgery, Reprocessed
- Reason
- Reusable access port system may crack or seperate during use.
- Root cause
- Device Design
- Quantity
- 2838 units
- 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
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K201511
- Location
- Tempe, AZ, United States