FDA-Device2026-09-23Class IIPROCESSING DEFECT
Ethicon Xcel Bladeless Trocar recalled for crack or separation risk during use
What this means
The reusable access port system in this surgical trocar may crack or separate during use. This affects specific lot numbers manufactured by Ethicon Endo-Surgery, Inc. and distributed by Stryker Sustainability Solutions.
- Check your inventory against the affected lot numbers listed in the FDA notice.
- Stop using affected units immediately.
- Contact your supplier or Ethicon Endo-Surgery for instructions on replacement or return.
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
205,704 units
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3186-2026More Stryker recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.