Z-3185-2026Class II

REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM

Name: Z-3185-2026 REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
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-3185-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-19
Posted: 2026-09-16
Recalling firm: Stryker Sustainability Solutions
Product: REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
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: 2682 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)00885825020897/ Lots: 16029001 16032878 16038822 16041414 16044000 16048542 16052751 16054119 16062169 16062738 16066292 16074632 16087947 16087952 16090650 16098040 16107246 16111434 16115899 16115909 16120868 16130680 16130701 16135456 16136279 16138395 16140432 16140568 16142544 16142619 16159304 16160563 16172080 16176548 16186738 16186874 16187194 16187248 16187457 16197336 16201786 16205783 16205810 16205823 16206753 16220653 16220918 16221448 16221453

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3185-2026
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)