FDA Medical devices recall ·
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY… recall
- Recall number
- Z-3187-2026
- Date
- (initiated August 19, 2026)
- Company / brand
- Stryker Sustainability Solutions
1810 W Drake Dr, Tempe, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9072 UNITS
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Why was it recalled?
Reusable access port system may crack or seperate during use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Alaska Alabama Arkansas Arizona California Colorado District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3187-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.