FDA-Device2026-09-23Class IIPROCESSING DEFECT
Ethicon XCEL Bladeless Trocar with OptiView recalled for reusable port cracking risk
What this means
The reusable access port system in certain Ethicon XCEL Bladeless Trocars may crack or separate during surgical use. This could affect the instrument's function during a procedure. The affected units have been distributed nationwide and internationally.
- Check your facility's inventory against the lot numbers listed in the recall notice.
- Quarantine and discontinue use of affected units immediately.
- Contact your Ethicon sales representative or the FDA for return and replacement instructions.
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
7,5966 units
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3182-2026More Stryker recalls
- FDA-Device2026-09-23Ethicon XCEL Bladeless Trocar recalled for potential cracking or separation during use
- 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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