FDA-Device2026-09-23Class IIPROCESSING DEFECT
Ethicon Xcel Bladeless Trocar recalled for potential cracking or separation during surgery
What this means
Ethicon Endo-Surgery's Xcel Bladeless Trocar with Stability Sleeve (12×100mm) reusable access port system may crack or separate during surgical use. The device is used in minimally invasive procedures. Approximately 2,682 units are affected across multiple lot numbers.
- Check if your facility uses this device by matching the lot numbers on the packaging.
- Contact Ethicon or your hospital's surgical equipment manager for instructions on affected units.
- Do not use affected devices until you receive corrective guidance from Ethicon or the FDA.
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
2682 units
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3185-2026More 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 use
- 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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