Fresh Recalls

FDAClass II · Medical device · Recall Z-3184-2026 · Recalled September 23, 2026

REF recall — Stryker Sustainability Solutions

Agency report date: September 23, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
REF
Company / brand
Stryker Sustainability Solutions
Lot / serial / date codes
UDI: (01)00885825014278/ Lots: 16029055 16032602 16043960 16061865 16070321 16087746 16098637 16110046 16114368 16130717 16135711 16143130 16146135 16151146 16160441 16168393 16176147 16181210 16193613 16193841 16197273 16210637 16225560 16234068 16243073 16255238 16270273 16281198 16288334 16294565 16297693 16298302 16330851 16331282 16343635 16347401 16371411 16371424 16388088 16403183 16403718 16414106 16427432 16431368 16447949 16467342 16477495 16487698 16494506 16500580 16508571 16521742 16532270 16535613 16535744 16548007 16555888 16570108 16574637 16587696 16587715 16590797 16599333 16599403 16604291 16608764 16623439 16633133 16645377 16651357 16652029 16655384 16665681 16674817 16675666 16705350 16705494 16713074 16716790 16721202 16729496 16745595 16746009 16759208 16763700 16774402 16778721 16793395 16796870 16806597 16813889 16818038 16826959 16830829 16841701 16845712 16850270 16854348 16864262 16873298 16882066 16890447 16910583 16911077 16918348 16932643 16932670 16944854 16948846 16954589 16954752 16960057 16973101 16997240 17001744 17028440 17028570 17031601 17041299 17049923 17059628 17066538 17076463 17088783 17095646 17109581 17113435 17135548 17139463 17150688 17151102 17169646 17170177 17204941 17205450 17209368 17209375 17227100 17251065 17254141 17263845 17271186 17271210 17281823 17294417 17299147 17322114 17328034 17341513 17368858 17390430 17403535 17403664 17403934 17425110 17429906 17449215 17469249 17473233 17481923 17505258 17505372 17526291 17540762 17551599 17565554 17581089 17596921 17608897 17609204 17623498 17630896 17655989 17669388 17688040 17691616
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.
Agency product description and boundaries

REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Reusable access port system may crack or seperate during use.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: REF recall status

3. Open the official notice or contact

Official recall ID
Z-3184-2026
Brand
All Stryker Sustainability Solutions recalls
Classification
Class II
Units affected
25746 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Tempe, AZ, United States
Firm address
1810 W Drake Dr, N/A, 85283-4327

Identifying details (verbatim from the notice)

Product codes / lots
UDI: (01)00885825014278/ Lots: 16029055 16032602 16043960 16061865 16070321 16087746 16098637 16110046 16114368 16130717 16135711 16143130 16146135 16151146 16160441 16168393 16176147 16181210 16193613 16193841 16197273 16210637 16225560 16234068 16243073 16255238 16270273 16281198 16288334 16294565 16297693 16298302 16330851 16331282 16343635 16347401 16371411 16371424 16388088 16403183 16403718 16414106 16427432 16431368 16447949 16467342 16477495 16487698 16494506 16500580 16508571 16521742 16532270 16535613 16535744 16548007 16555888 16570108 16574637 16587696 16587715 16590797 16599333 16599403 16604291 16608764 16623439 16633133 16645377 16651357 16652029 16655384 16665681 16674817 16675666 16705350 16705494 16713074 16716790 16721202 16729496 16745595 16746009 16759208 16763700 16774402 16778721 16793395 16796870 16806597 16813889 16818038 16826959 16830829 16841701 16845712 16850270 16854348 16864262 16873298 16882066 16890447 16910583 16911077 16918348 16932643 16932670 16944854 16948846 16954589 16954752 16960057 16973101 16997240 17001744 17028440 17028570 17031601 17041299 17049923 17059628 17066538 17076463 17088783 17095646 17109581 17113435 17135548 17139463 17150688 17151102 17169646 17170177 17204941 17205450 17209368 17209375 17227100 17251065 17254141 17263845 17271186 17271210 17281823 17294417 17299147 17322114 17328034 17341513 17368858 17390430 17403535 17403664 17403934 17425110 17429906 17449215 17469249 17473233 17481923 17505258 17505372 17526291 17540762 17551599 17565554 17581089 17596921 17608897 17609204 17623498 17630896 17655989 17669388 17688040 17691616
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.
Firm notified the public via
N/A
FDA event ID
99634
Recall initiated
August 19, 2026
FDA classified
September 16, 2026
FDA report date
September 23, 2026

Other medical device recalls from around the same time

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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