REF:2B5LT Ethicon Endo-Surgery, Inc
Medical device recall Z-3182-2026. Published in FDA’s Enforcement Report on Sep 23, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 23, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 49 states named
- 7,5966 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Reusable access port system may crack or seperate during use.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
7,5966 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: (01)00885825017248/ Lots: 16029709 16029713 16029905 16038879 16038908 16048968 16048981 16051646 16052906 16053263 16070603 16070983 16074134 16074530 16074759 16092016 16092379 16092572 16104843 16106180 16119023 16119800 16121093…
Every code shown here, 1,993 characters
UDI: (01)00885825017248/ Lots: 16029709 16029713 16029905 16038879 16038908 16048968 16048981 16051646 16052906 16053263 16070603 16070983 16074134 16074530 16074759 16092016 16092379 16092572 16104843 16106180 16119023 16119800 16121093 16126431 16126844 16140581 16140608 16140727 16140736 16142688 16160592 16160707 16160912 16161351 16167914 16180911 16188469 16189136 16197549 16210951 16244569 16247119 16247126 16250185 16255569 16267787 16273355 16284965 16303304 16306443 16359846 16360045 16360239 16360667 16364426 16383244 16383259 16384055 16396887 16397027 16427445 16435623 16435843 16436420 16436477 16444099 16444580 16444611 16448679 16448717 16459282 16459305 16459333 16459564 16470988 16488281 16491642 16492270 16492579 16492580 16500270 16500301 16500355 16500477 16508036 16528627 16528847 16531603 16531776 16531851 16552151 16552167 16552179 16552302 16555583 16614437 16614471 16618155 16626048 16637792 16646115 16651856 16652489 16657339 16662201 16682817 16701240 16713799 16713813 16716081 16738446 16746148 16754258 16754364 16759556 16773257 16774058 16774101 16774234 16782321 16800707 16806623 16806634 16806725 16814724 16830838 16841362 16841565 16845689 16854686 16873543 16882583 16883091 16889712 16899476 16911147 16914777 16918170 16918780 16923307 16940703 16944189 16948321 16952138 16952313 16977312 16981100 16981383 16981401 16985146 17001229 17005661 17010282 17010765 17010777 17033172 17035546 17040809 17041439 17045802 17063970 17064018 17080237 17085115 17085162 17108912 17109146 17109620 17112702 17121236 17139503 17139820 17147232 17150268 17150996 17174600 17175063 17175092 17175156 17178723 17185753 17185920 17189274 17189482 17189760 17200395 17200428 17200459 17209470 17209525 17232002 17235037 17235643 17235658 17239757 17251106 17258526 17258722 17258808 17258820 17275106 17289383 17289591 17289995 17294320 17310764 17325423 17325475 17327721 17327882 17341993 17345967 17346016 17353315 17353701 17369590 17369751 17378860…
FDA’s list runs to 2,280 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
49 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 19, 2026.
- FDA classified it on Sep 16, 2026.
- FDA’s Enforcement Report published it on Sep 23, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Sustainability Solutions, of Tempe, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: N/A.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,280 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.