Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MMsee related information
Date Initiated by FirmAugust 19, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3184-2026
Recall Event ID 99634
510(K)NumberK201511 
Product Classification Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
ProductREF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
Code Information 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
FEI Number 3009350690
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information ContactStryker Customer Service
800-624-4422
Manufacturer Reason
for Recall		Reusable access port system may crack or seperate during use.
FDA Determined
Cause 2		Device Design
ActionOn August 19, 2026, Stryker Sustainability Solutions (SSS)issued a Urgent: Medical Device recall notice to affected consignees via sales representative and US Mail. SSS ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Immediately check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Complete the Business Reply Form or use the QR Code on Attachment A. Response is required. a.If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility.
Quantity in Commerce25746 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NLM
-
-