CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled

Stryker Sustainability Solutions is recalling REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar, distributed nationwide in the US. The recall was initiated on 19 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (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

Quantity recalled2682 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3185-2026
FDA event ID: 99634
Recalling firm: Stryker Sustainability Solutions, Tempe, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 19 Aug 2026
FDA classified: 16 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

19 Aug 2026	Recall initiated by company
16 Sep 2026	Classified by FDA	+28 days
23 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reusable access port system may crack or seperate during use.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Reusable access port system may crack or seperate during use.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 99634

This product is part of a recall event; the main page for the event is REF:2B5ST Ethicon Endo-Surgery recalled by Stryker Sustainability.

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026	CLASS II	REF:2B5ST Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026	CLASS II	REF:B5ST Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026	CLASS II	REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026	CLASS II	REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide

Other Surgical Instruments recalls

All 3,816

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5ST Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide