FDA-Device2026-09-23Class IIPROCESSING DEFECT
Ethicon Endo-Surgery XCEL Bladeless Trocar recalled for cracking or separation during use
What this means
Ethicon Endo-Surgery's XCEL Bladeless Trocar with Stability Sleeve (5×75 mm) may crack or separate during surgical use. The reusable access port system in affected lots could fail during a procedure.
- If you use or manage this device, stop using affected lots immediately.
- Check if you have inventory matching the listed lot numbers.
- Contact Ethicon Endo-Surgery or your supplier for guidance on device replacement or return.
- Report any incidents or injuries to the FDA MedWatch program.
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
9072 UNITS
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3187-2026More Stryker recalls
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for crack or separation risk during use
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for reusable access port cracking risk
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