FDA recall record

Stryker Sustainability Solutions REF:2B5LT Ethicon Endo-Surgery, Inc recall — FDA Z-3182-2026

Reusable access port system may crack or seperate during use.

Class IIclassification
Z-3182-2026official record ID
Sep 23, 2026report date

Recall record at a glance

Official recordZ-3182-2026
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmStryker Sustainability Solutions
Report dateSep 23, 2026
Recall initiation dateAug 19, 2026
Quantity7,5966 units
LocationTempe, AZ, United States

Official product description

REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM

Why the product was recalled

Reusable access port system may crack or seperate during use.

Distribution information

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.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: N/A.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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