Device recall
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
- Recall number
- Z-3185-2026
- Event id
- 99634
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Stryker Sustainability Solutions
- Report date
- Sep 23, 2026
- Posted
- Sep 16, 2026
- Initiated
- Aug 19, 2026
- Center classification date
- Sep 16, 2026
- Product code
- NLM
- Device type
- Laparoscope, General & Plastic Surgery, Reprocessed
- Reason
- Reusable access port system may crack or seperate during use.
- Root cause
- Device Design
- Quantity
- 2682 units
- Code info
- UDI: (01)00885825020897/ Lots: 16029001 16032878 16038822 16041414 16044000 16048542 16052751 16054119 16062169 16062738 16066292 16074632 16087947 16087952 16090650 16098040 16107246 16111434 16115899 16115909 16120868 16130680 16130701 16135456 16136279 16138395 16140432 16140568 16142544 16142619 16159304 16160563 16172080 16176548 16186738 16186874 16187194 16187248 16187457 16197336 16201786 16205783 16205810 16205823 16206753 16220653 16220918 16221448 16221453
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K201511
- Location
- Tempe, AZ, United States