REF:B5LT Ethicon Endo-Surgery, Inc
Medical device recall Z-3186-2026. 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
- 205,704 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:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
205,704 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: (01)00885825014193/ Lots: 16028826 16028944 16032429 16032455 16037857 16042594 16043150 16046641 16048041 16048162 16052733 16062124 16066285 16070101 16070223 16070912 16074744 16084153 16087588 16096162 16098296 16099148 16111195…
Every code shown here, 1,993 characters
UDI: (01)00885825014193/ Lots: 16028826 16028944 16032429 16032455 16037857 16042594 16043150 16046641 16048041 16048162 16052733 16062124 16066285 16070101 16070223 16070912 16074744 16084153 16087588 16096162 16098296 16099148 16111195 16111423 16112459 16115071 16120538 16126420 16126902 16131433 16135397 16135402 16139681 16140445 16142642 16142674 16146017 16146188 16146587 16147022 16155907 16156189 16160070 16160805 16160867 16161367 16168109 16168270 16172196 16172940 16177138 16177252 16180562 16188453 16189060 16189428 16192354 16192768 16197315 16201740 16202087 16202127 16207388 16210404 16213753 16214274 16214290 16222349 16224767 16225404 16229770 16233367 16237281 16238596 16246288 16247086 16247491 16252145 16259463 16266998 16270336 16273726 16273956 16281200 16281683 16285515 16293349 16298285 16298478 16303182 16303680 16306399 16310061 16310747 16313556 16317868 16331016 16331380 16335107 16338939 16339687 16339734 16346961 16347809 16347813 16354890 16359193 16376457 16379762 16379864 16379961 16383758 16387666 16397456 16397619 16397931 16403371 16407611 16408119 16412167 16412599 16414020 16414054 16414065 16422560 16422600 16422933 16427552 16431525 16432498 16432507 16436431 16439954 16444010 16444567 16447384 16448499 16463568 16463942 16467181 16467650 16470838 16471034 16478044 16482171 16483326 16486966 16494727 16494935 16500081 16503467 16508223 16512647 16514742 16514973 16520919 16521034 16523273 16523549 16523565 16528044 16532204 16532215 16535609 16536045 16540085 16540333 16540517 16540689 16547526 16548167 16548318 16551731 16558496 16564366 16569596 16569622 16574212 16574659 16579579 16584194 16587228 16587581 16587599 16587736 16591025 16595892 16596095 16596114 16600039 16603754 16604695 16609142 16609161 16614416 16615103 16623186 16623193 16626466 16626497 16626654 16626665 16632209 16642253 16642426 16645809 16656924 16656969 16660783 16661882 16665794 16665827 16670396 16671062 16674801 16675678 16679865 16679877…
FDA’s list runs to 4,809 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 4,809 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.