FDAClass IISeptember 23, 2026

REF:B5ST Ethicon Endo-Surgery recall

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

Why was REF:B5ST Ethicon Endo-Surgery recalled?

Reusable access port system may crack or seperate during use.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Recalling firm
Stryker Sustainability Solutions
Quantity
9072 UNITS
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.
Recall date
September 23, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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