FDAFDA recall Z-3185-2026 · Sep 23, 2026
Stryker Sustainability Solutions: REF:B12LT Ethicon Endo-Surgery recall
Recall found
Product
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Reason for recall
Reusable access port system may crack or seperate during use.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- 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.
- Recalling firm
- Stryker Sustainability Solutions, Tempe, AZ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-19
Source: openFDA enforcement record Z-3185-2026 · search recall number Z-3185-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.