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U.S. Department of Health and Human Services

Class 2 Device Recall XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM

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 Class 2 Device Recall XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MMsee related information
Date Initiated by FirmAugust 19, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3182-2026
Recall Event ID 99634
510(K)NumberK201511 
Product Classification Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
ProductREF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
Code Information 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 17378873 17378943 17390891 17391078 17391084 17408075 17408145 17420057 17420185 17430762 17431184 17431364 17449546 17456945 17469587 17473527 17473747 17496222 17500265 17511819 17521462 17525917 17541289 17545348 17545353 17551198 17551484 17576887 17608061 17608438 17608799 17614359
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 Commerce7,5966 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
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