REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Summary
The FDA issued a Class II for REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE by Stryker Sustainability Solutions. Reason: Reusable access port system may crack or seperate during use..
Details
Source
Device Recall
External ID
Z-3185-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Lot/Code Info: 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
Quantity Affected: 2682 units
Reason for Recall
Reusable access port system may crack or seperate during use.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-19
Company
Tempe, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Stryker Sustainability Solutions has 53 FDA actions in our database, including 41 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Sustainability Solutions) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Sustainability Solutions have FDA actions?
Stryker Sustainability Solutions has 53 FDA actions in our database, including 41 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3185-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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