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REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM

Class II
Recalling firm
Stryker Sustainability Solutions
Reason for recall
Reusable access port system may crack or seperate during use.
Affected products (lot / model / serial)
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
Units affected
9072 UNITS
Distribution pattern
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.
Firm location
Tempe, AZ, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
N/A
Product type
Devices
Status
Ongoing
Recall number
Z-3187-2026
Recall initiated
August 19, 2026
FDA classification date
September 16, 2026
FDA report date
September 23, 2026
FDA event ID
99634
Last updated on HTM Vibe
September 29, 2026
View on openFDA