FDA-Device2026-09-23Class IIPROCESSING DEFECT
Ethicon XCEL Bladeless Trocar recalled for potential cracking or separation during use
What this means
The reusable access port system in this surgical trocar may crack or separate during use. This could compromise the integrity of the device during laparoscopic procedures. The recall affects approximately 25,746 units distributed nationwide and in Canada and Israel.
- Check if your facility uses affected lot numbers (16029055 through 17691616; see full list in official notice)
- Stop using affected units immediately
- Contact your Ethicon representative or the FDA for return and replacement instructions
- Review affected surgical cases for any patient complications
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
25746 units
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3184-2026More Stryker recalls
- FDA-Device2026-09-23Ethicon XCEL Bladeless Trocar with OptiView recalled for reusable port cracking risk
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for potential cracking or separation during surgery
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for crack or separation risk during use
- FDA-Device2026-09-23Ethicon Endo-Surgery XCEL Bladeless Trocar recalled for cracking or separation during use
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for reusable access port cracking risk
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