Class 2 Device Recall XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM

• Date Initiated by Firm: August 19, 2026
• Date Posted: September 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3186-2026
• Recall Event ID: 99634
• 510(K)Number: K201511
• Product Classification: Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
• Product: REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
• Code Information: 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 16682151 16682770 16687462 16692140 16692172 16692268 16696265 16700452 16700900 16705193 16709261 16709385 16709597 16709610 16713775 16713781 16716514 16717266 16721050 16721916 16725305 16725875 16725966 16728591 16732890 16737969 16741456 16741879 16742023 16745357 16745771 16746452 16749189 16750018 16754567 16755302 16758520 16763958 16764025 16767256 16767679 16768101 16768268 16774043 16778869 16781973 16785617 16789405 16792840 16793382 16796858 16797142 16797347 16807208 16811095 16811228 16811568 16814350 16814418 16817477 16817757 16817788 16817987 16826107 16826370 16826963 16833717 16834312 16834349 16837699 16838194 16838333 16841260 16841916 16842018 16845474 16849412 16850166 16854162 16854213 16857842 16860629 16860751 16860767 16860831 16869637 16869721 16872825 16873251 16877561 16877883 16878069 16886421 16886935 16890605 16892824 16893355 16894173 16899699 16902792 16908076 16911020 16911293 16919131 16922631 16922893 16923209 16926760 16927072 16936127 16936353 16936617 16936849 16943569 16949133 16951816 16953009 16954618 16959414 16960486 16963979 16964534 16964919 16969877 16973313 16978181 16980910 16984757 16985053 16987949 16997152 16997388 17001621 17004314 17005585 17010314 17010435 17013747 17013969 17017025 17020363 17020787 17024283 17024616 17035669 17036024 17041234 17041247 17050307 17053749 17055829 17055864 17060150 17063361 17067202 17070414 17076883 17081132 17084251 17085588 17089008 17095605 17099768 17099821 17103507 17103873 17109409 17116792 17116802 17120683 17120840 17131833 17131867 17135991 17136260 17136475 17139574 17147250 17151322 17155294 17158669 17159832 17165781 17165911 17169963 17171111 17173926 17173935 17190539 17199367 17199403 17199419 17199658 17204598 17205855 17209824 17219974 17227455 17228106 17235978 17235984 17247109 17249835 17250583 17250900 17254806 17254810 17258503 17258975 17259005 17266994 17267162 17275181 17281708 17282387 17282445 17285944 17286328 17286337 17290122 17293900 17299077 17303639 17304084 17321419 17321670 17325362 17325614 17333371 17337653 17341257 17358207 17363462 17364053 17378201 17378553 17378650 17403073 17407979 17412823 17413288 17417109 17417579 17417676 17425678 17425887 17436001 17436040 17441287 17442039 17448781 17454162 17468565 17471347 17474066 17481348 17482218 17491511 17492064 17505393 17512416 17517569 17520689 17525578 17532462 17535912 17536383 17545136 17550422 17557081 17557132 17565241 17565764 17571924 17575872 17576264 17580429 17590902 17591112 17596913 17600177 17600219 17600226 17600274 17600328 17602104 17602975 17603011 17606494 17614337 17618361 17618716 17623697 17623873 17635903 17641398 17641403 17645985 17655904 17664504 17664897 17669134 17669357 17678849 17688093 17688998 17692201 17703119 17708606 17712528 17713130 17715999 17722453
• FEI Number: 3009350690
• Recalling Firm/ Manufacturer: Stryker Sustainability Solutions; 1810 W Drake Dr; Tempe AZ 85283-4327
• For Additional Information Contact: Stryker Customer Service; 800-624-4422
• Manufacturer Reason for Recall: Reusable access port system may crack or seperate during use.
• FDA Determined Cause: Device Design
• Action: On 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 Commerce: 205,704 units
• 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.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = NLM