Z-3187-2026Class II

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

Name: Z-3187-2026 REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Creator: Stryker Sustainability Solutions
Published: 2026-08-19
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2026-08-19 / Open, Classified

FDA source

Recall record

Recall number: Z-3187-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-19
Posted: 2026-09-16
Recalling firm: Stryker Sustainability Solutions
Product: REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Product code: NLM Laparoscope, General & Plastic Surgery, Reprocessed
Reason for recall: Reusable access port system may crack or seperate during use.
FDA root cause: Device Design
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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3187-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3182-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3183-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3184-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3185-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3186-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3187-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code NLM

K201511Class IIReprocessed Endoscopic Trocars and SleevesStryker Sustainability Solutions / cleared 2020-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)