FDA-Device2026-09-23Class IIPROCESSING DEFECT
Ethicon Xcel Bladeless Trocar recalled for reusable access port cracking risk
What this means
Ethicon Endo-Surgery's Xcel Bladeless Trocar with OptiView Technology (5mm × 75mm) has a reusable access port system that may crack or separate during surgical use. Approximately 2,838 units have been distributed across the US, Canada, and Israel. No injuries have been reported to date.
- If you use or have this device in your facility, check the lot numbers listed in the recall notice (starting with 16188647 through 17389157).
- Do not use affected units until you receive further instructions from Ethicon Endo-Surgery.
- Contact Ethicon Endo-Surgery or your device representative for guidance on inspection, repair, or replacement options.
The agency's original wording
Hazard
Reusable access port system may crack or seperate during use.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
2838 units
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3183-2026More Stryker recalls
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