Device recall
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
- Recall number
- Z-3187-2026
- 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
- 9072 UNITS
- Code info
- UDI:(01)00885825014254/ Lots: 16028740 16083100 16098933 16106547 16130667 16160384 16160418 16160460 16181332 16201793 16207031 16234052 16264116 16418941 16421915 16422882 16476685 16493231 16948345 16954673 16977948 16993151 17151380 17160201 17210355 17239624 17271015 17271027 17324927 17341521 17342144 17378894 17412852 17426084 17457260 17491569 17499741 17512459 17521310 17526338
- 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