Open, Classified

REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM

FDA Recall Z-3186-2026 · Posted 2026-09-16

Recalling FirmStryker Sustainability Solutions

Recall StatusOpen, Classified

Product CodeNLM

Date Initiated2026-08-19

Product Quantity205,704 units

Reason for Recall

Reusable access port system may crack or seperate during use.

Firm Action

On August 19, 2026, Stryker Sustainability Solutions (SSS)issued a Urgent: Medical Device recall notice to affected consignees via sales representative and US Mail. SSS ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Immediately check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Complete the Business Reply Form or use the QR Code on Attachment A. Response is required. a.If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201511Reprocessed Endoscopic Trocars and SleevesStryker Sustainability Solutions · 2020-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.