{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "222032", "product_res_number": "Z-3182-2026", "event_date_initiated": "2026-08-19", "event_date_posted": "2026-09-16", "recall_status": "Open, Classified", "res_event_number": "99634", "product_code": "NLM", "k_numbers": [ "K201511" ], "product_description": "REF:2B5LT\r\nEthicon Endo-Surgery, Inc. \r\nXCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM", "code_info": "UDI: (01)00885825017248/ Lots: 16029709\t16029713 16029905\t\t16038879\t\t16038908\n16048968\t16048981\t\t\t16051646\t\t16052906\t\t16053263\n16070603\t16070983\t\t\t16074134\t\t16074530\t\t16074759\n16092016\t16092379\t\t\t16092572\t\t16104843\t\t16106180\n16119023\t16119800\t\t\t16121093\t\t16126431\t\t16126844\n16140581\t16140608\t\t\t16140727\t\t16140736\t\t16142688\n16160592\t16160707\t\t\t16160912\t\t16161351\t\t16167914\n16180911\t16188469\t\t\t16189136\t\t16197549\t\t16210951\n16244569\t16247119\t\t\t16247126\t\t16250185\t\t16255569\n16267787\t16273355\t\t\t16284965\t\t16303304\t\t16306443\n16359846\t16360045\t\t\t16360239\t\t16360667\t\t16364426\n16383244\t16383259\t\t\t16384055\t\t16396887\t\t16397027\n16427445\t16435623\t\t\t16435843\t\t16436420\t\t16436477\n16444099\t16444580\t\t\t16444611\t\t16448679\t\t16448717\n16459282\t16459305\t\t\t16459333\t\t16459564\t\t16470988\n16488281\t16491642\t\t\t16492270\t\t16492579\t\t16492580\n16500270\t16500301\t\t\t16500355\t\t16500477\t\t16508036\n16528627\t16528847\t\t\t16531603\t\t16531776\t\t16531851\n16552151\t16552167\t\t\t16552179\t\t16552302\t\t16555583\n16614437\t16614471\t\t\t16618155\t\t16626048\t\t16637792\n16646115\t16651856\t\t\t16652489\t\t16657339\t\t16662201\n16682817\t16701240\t\t\t16713799\t\t16713813\t\t16716081\n16738446\t16746148\t\t\t16754258\t\t16754364\t\t16759556\n16773257\t16774058\t\t\t16774101\t\t16774234\t\t16782321\n16800707\t16806623\t\t\t16806634\t\t16806725\t\t16814724\n16830838\t16841362\t\t\t16841565\t\t16845689\t\t16854686\n16873543\t16882583\t\t\t16883091\t\t16889712\t\t16899476\n16911147\t16914777\t\t\t16918170\t\t16918780\t\t16923307\n16940703\t16944189\t\t\t16948321\t\t16952138\t\t16952313\n16977312\t16981100\t\t\t16981383\t\t16981401\t\t16985146\n17001229\t17005661\t\t\t17010282\t\t17010765\t\t17010777\n17033172\t17035546\t\t\t17040809\t\t17041439\t\t17045802\n17063970\t17064018\t\t\t17080237\t\t17085115\t\t17085162\n17108912\t17109146\t\t\t17109620\t\t17112702\t\t17121236\n17139503\t17139820\t\t\t17147232\t\t17150268\t\t17150996\n17174600\t17175063\t\t\t17175092\t\t17175156\t\t17178723\n17185753\t17185920\t\t\t17189274\t\t17189482\t\t17189760\n17200395\t17200428\t\t17200459\t\t\t17209470\t\t17209525\n17232002\t17235037\t\t17235643\t\t\t17235658\t\t17239757\n17251106\t17258526\t\t17258722\t\t\t17258808\t\t17258820\n17275106\t17289383\t\t17289591\t\t\t17289995\t\t17294320\n17310764\t17325423\t\t17325475\t\t\t17327721\t\t17327882\n17341993\t17345967\t\t17346016\t\t\t17353315\t\t17353701\n17369590\t17369751\t\t17378860\t\t\t17378873\t\t17378943\n17390891\t17391078\t\t17391084\t\t\t17408075\t\t17408145\n17420057\t17420185\t\t17430762\t\t\t17431184\t\t17431364\n17449546\t17456945\t\t17469587\t\t\t17473527\t\t17473747\n17496222\t17500265\t\t17511819\t\t\t17521462\t\t17525917\n17541289\t17545348\t\t17545353\t\t\t17551198\t\t17551484\n17576887\t17608061\t\t17608438\t\t\t17608799\t\t17614359", "firm_fei_number": "3009350690", "recalling_firm": "Stryker Sustainability Solutions", "address_1": "1810 W Drake Dr", "city": "Tempe", "state": "AZ", "postal_code": "85283-4327", "additional_info_contact": "Stryker Customer Service\n800-624-4422", "reason_for_recall": "Reusable access port system may crack or seperate during use.", "root_cause_description": "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: \n\n1. Inform individuals within your organization who need to be aware of this action.\n2. Immediately check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use.\n3. Complete the Business Reply Form or use the QR Code on Attachment A. Response is required.\na.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.\n4. Maintain awareness of this communication internally until all required actions have been completed within your facility.", "product_quantity": "7,5966 units", "distribution_pattern": "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\t, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel and Canada.", "openfda": { "k_number": [ "K132629", "K121240", "K060676", "K024015", "K133414", "K100080", "K012578", "K172093", "K043592", "K062497", "K111002", "K012644", "K052299", "K172097", "K070059", "K201511", "K160740", "K043594", "K063788", "K182828", "K053585", "K043253", "K153258" ], "registration_number": [ "1061124", "1650907", "3035387162", "3032391", "1018470", "3020163307", "1056128", "3013188547", "3009350690", "3014461810", "2011171", "1417592", "3011024991", "3014023545", "3015453963", "3030153385", "3021477808" ], "fei_number": [ "3035387162", "1018470", "3020163307", "1000512168", "3013188547", "3002299608", "3009350690", "3014461810", "2011171", "1417592", "3011024991", "3014023545", "1000132435", "3015453963", "3002681132", "3030153385", "3021477808" ], "device_name": "Laparoscope, General & Plastic Surgery, Reprocessed", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }