{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "193173", "product_res_number": "Z-1234-2022", "event_date_initiated": "2022-05-03", "event_date_created": "2022-06-03", "recall_status": "Open, Classified", "res_event_number": "90025", "product_code": "FAJ", "k_numbers": [ "K202957" ], "product_description": "STORZ KARL STORZ-ENDOSKOPE\n\nREF 11272VUE CMOS Video Cysto-Urethroscope\nREF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT\n\nREF 11272VUE-R CMOS Video Cysto-Urethroscope\nREF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT", "code_info": "Scope Base Part Number(s): 11272VUE\nScope Kit Part Number: 11272VUEK\nUDI Code-DI: 4048551431382\nSerial Numbers:\n25407\n32321\n38539\n53439\n58011\n58143\n58546\n59051\n25408\n32389\n40370\n53574\n58020\n58144\n58557\n59063\n25410\n32391\n40371\n53575\n58021\n58145\n58558\n59093\n25766\n32417\n40707\n53589\n58022\n58156\n58567\n59094\n28096\n32994\n40708\n53593\n58045\n58157\n58569\n59095\n28257\n33787\n41249\n53627\n58046\n58183\n58570\n59096\n28919\n33802\n44912\n53628\n58047\n58184\n58663\n59098\n29286\n33804\n45546\n53632\n58048\n58185\n58665\n59122\n29342\n33905\n46190\n53634\n58058\n58423\n58695\n59125\n30054\n33907\n46198\n53637\n58060\n58445\n58722\n59152\n30881\n34465\n47625\n53737\n58062\n58446\n58723\n59153\n31033\n34724\n47669\n53776\n58073\n58449\n58730\n59179\n31036\n34725\n48191\n53833\n58074\n58451\n58731\n59201\n31038\n35188\n48462\n53834\n58075\n58476\n59005\n59202\n31300\n36020\n48540\n54289\n58078\n58498\n59006\n59203\n31302\n36371\n48553\n57603\n58087\n58503\n59007\n59223\n31374\n36470\n49090\n57606\n58088\n58506\n59032\n59342\n31413\n36583\n49165\n57607\n58089\n58508\n59033\n59343\n31533\n36820\n52783\n57609\n58090\n58516\n59034\n59344\n31622\n37462\n53204\n57610\n58125\n58517\n59038\n59345\n31964\n38536\n53429\n57986\n58142\n58545\n59048\n59398\n59399\n59630\n59815\n59939\n60080\n60352\n60860\n61226\n59400\n59631\n59819\n59940\n60151\n60385\n60885\n61228\n59401\n59632\n59820\n59968\n60153\n60386\n60948\n61230\n59402\n59633\n59821\n59969\n60154\n60416\n60949\n61236\n59416\n59635\n59822\n59970\n60159\n60417\n61109\n61238\n59418\n59637\n59839\n59971\n60160\n60418\n61110\n61242\n59420\n59639\n59840\n60001\n60161\n60430\n61111\n61243\n59495\n59640\n59842\n60002\n60162\n60520\n61114\n61246\n59497\n59660\n59848\n60003\n60193\n60522\n61115\n61253\n59581\n59662\n59851\n60004\n60201\n60525\n61116\n61257\n59582\n59663\n59853\n60005\n60202\n60526\n61136\n61258\n59584\n59664\n59856\n60007\n60203\n60527\n61137\n61259\n59587\n59665\n59888\n60008\n60205\n60752\n61139\n61270\n59589\n59666\n59890\n60025\n60297\n60775\n61140\n61300\n59592\n59667\n59891\n60027\n60299\n60776\n61155\n62618\n59593\n59668\n59892\n60064\n60300\n60778\n61156\n59594\n59692\n59896\n60066\n60301\n60780\n61190\n59600\n59694\n59897\n60067\n60312\n60820\n61191\n59602\n59695\n59921\n60068\n60314\n60838\n61192\n59603\n59699\n59935\n60076\n60315\n60839\n61193\n59604\n59813\n59936\n60077\n60331\n60841\n61194\n59628\n59814\n59938\n60079\n60350\n60859\n61224\n \nScope Kit Number(s): 11272VUK-R\nScope Kit Part Number: 11272VUEK-R\nUDI Code-DI: 4048551444351\nSerial Numbers:\n25894\n37977\n48678\n58399\n59872\n60163\n60316\n60930\n25898\n38237\n49374\n58424\n59873\n60164\n60325\n61141\n27983\n38542\n49376\n58467\n59874\n60208\n60388\n61142\n30293\n40571\n51596\n58468\n59875\n60209\n60420\n61232\n31667\n40572\n55498\n58512\n59876\n60298\n60429\n61234\n31730\n40706\n57611\n58645\n60022\n60302\n60512\n61268\n32409\n44105\n58122\n58711\n60023\n60303\n60724\n61269\n34423\n46522\n58398\n59554\n60024\n60304\n60836\n62359", "firm_fei_number": "3007475226", "recalling_firm": "Karl Storz Endoscopy", "address_1": "2151 E Grand Ave", "city": "El Segundo", "state": "CA", "postal_code": "90245-5017", "additional_info_contact": "Sedgwick\n877-877-0317", "reason_for_recall": "The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.", "root_cause_description": "Process control", "action": "On April 29, 2022, KARL STORZ sent an \"Urgent Medical Device Recall Notice\" Letter via UPS and posting to their website \"https://urldefense.com/v3/__https://www.karlstorzcustomerupdates.com/wp-content/uploads/2022/04/C-View-Recall-Customer-Notice.pdf__;!!Lw1uGqvHvtJ_psGG2Et-1voSwbo!bg5okg2Sm91SJG6RWtBKXJ258Z4YgfwOv4ZIuU_ZuW_tH2G1X_CNLBZeGB0YWAZEjDZ4j_-Hvlm6xzzWmhKnBU6U10FQtQHO$\" informing customers that certain serial numbers of the Flexible Video Cysto-Urethroscope may exhibit temporary loss of image when monopolar electrocautery is activated. Customers who are in possession of the identified scopes should discontinue use of the affected scopes and return them to KARL STORZ for replacement. Customers can confirm that Endoscope is part of the Recall by comparing the serial number to the serial numbers list in the Appendix.\n\nIn addition, if customers have already returned any affected scope(s) as part of the Reprocessing Methods Recall, they must still complete the enclosed Acknowledgment Form for this recall and return it as soon as possible via the contact information specified on the form.\nIf customer's Acknowledgment Form for the Reprocessing Methods Recall indicated that they have access to an appropriate sterilization method to sterilize the affected flexible endoscopes, then they will be eligible to have their C-View Endoscope(s) replaced by KARL STORZ. If they have not returned their Acknowledgment Form for the Reprocessing Methods Recall or if their Acknowledgement Form indicated that they do not have access to an appropriate sterilization method, then KARL STORZ will not be able to replace their C-View Endoscope(s) at this time.\n\nFor questions regarding this action, please use the contact information provided below for the recall execution partner, Sedgwick:\n\nTelephone: 877-877-0317\nFax: 877-597-9587\nE-Mail: karlstorz2935@sedgwick.com", "product_quantity": "401 units", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, and WY. The country of Canada.", "openfda": { "k_number": [ "K930827", "K051176", "K945527", "K250797", "K210512", "K223926", "K941779", "K252176", "K960872", "K170862", "K760179", "K895182", "K222162", "K243653", "K260649", "K902274", "K223040", "K160766", "K992983", "K202921", "K221690", "K012929", "K253905", "K240283", "K060899", "K221683", "K171500", "K221580", "K212202", "K253226", "K021074", "K181909", "K182876", "K860822", "K935278", "K242535", "K943176", "K040215", "K093665", "K231702", "K232837", "K260271", "K240663", "K993041", "K760274", "K980401", "K252598", "K241500", "K142194", "K072180", "K240227", "K030960", "K964037", "K992483", "K982620", "K253696", "K202957", "K243196", "K953201", "K033191", "K042225", "K043022", "K760189", "K240848", "K093725", "K922320", "K945262", "K253892", "K000197", "K191357", "K240849", "K171336", "K980592", "K251140", "K003807", "K003988", "K212476", "K251652", "K820851", "K222602", "K053560", "K120766", "K090814", "K231118", "K031141", "K182723", "K193095", "K914008", "K250269", "K042780", "K993689", "K970892" ], "registration_number": [ "3010398867", "3014211785", "3016045249", "1721676", "1526611", "3016667340", "9611503", "3008693678", "3037966040", "2648727", "3010707607", "3003687489", "1721504", "2518897", "3008494403", "3017961114", "3010419931", "3023102955", "3007829657", "3021246306", "3010399422", "3035710892", "3004215117", "2936485", "2431166", "1650907", "3012649202", "3009453258", "3011050570", "3012843412", "1037955", "3004361445", "1825146", "3015976667", "3036978610", "3010421104", "3015895045", "9611102", "9610595", "9610617", "3025349506", "8010047", "8030107", "3013247477", "1047843", "3013992977", "3018094310", "3020369549", "3015225571", "3011459664", "3022631687", "3012263546", "3004040397", "9614434", "3016881508", "3003637092", "9680718", "9515015", "3020746799", "3009171251", "3007127244", "1833700", "8010349", "3040391040", "9610691", "3044186618", "3008386005", "2084346", "1422634", "8010418", "3033589330", "9610773", "2243757", "3003915875", "2531475", "3016678045", "3004111573", "3004644065", "1651395", "2242464", "3006789154", "8043903", "3010202439", "3005580113", "3003790304", "3014644276", "3007710604", "3006546082", "2085947", "9680515", "1216677", "3015139943", "3033010858", "3024021261", "3015309643", "1820334", "3015316279", "3000279801", "9615001", "3033902430", "8010877", "8010298", "3007699067", "3012797688", "3002808148", "9612074", "3006554912", "1064858", "3006950086", "3014615697", "3003990090", "3029929134", "3010314836", "3012536737", "3017367014", "3027454635", "3010400865", "2030624", "3014342096", "1219930", "1724474", "9610877", "3029981244", "3010220595", "2020550", "3012375451", "1519132", "3003782610", "3005382983", "3015042209", "1418479", "3015972753", "9615393", "1221826", "1223490", "3008837339", "3013557562", "2183744" ], "fei_number": [ "3010398867", "3014211785", "3016045249", "1721676", "1526611", "3016667340", "3008693678", "3037966040", "2648727", "3010707607", "3003687489", "1721504", "3008494403", "3017961114", "3010419931", "3023102955", "3007829657", "3021246306", "3010399422", "3035710892", "3004215117", "2936485", "3012649202", "3009453258", "3002964398", "3002807798", "3011050570", "3012843412", "1037955", "3002681132", "3004361445", "3003448211", "1825146", "3015976667", "3036978610", "3010421104", "3015895045", "3025349506", "3013247477", "1047843", "3013992977", "3002808088", "3018094310", "3020369549", "3015225571", "3002808335", "3011459664", "3022631687", "3012263546", "3001642379", "3004040397", "1000124817", "3006149253", "3016881508", "1000115586", "3003637092", "3020746799", "3006759904", "3007127244", "3003276727", "3000219468", "3040391040", "3044186618", "3008386005", "3033589330", "3000206435", "3003915875", "2243757", "1000136543", "3016678045", "3004111573", "3003012447", "3004644065", "2242464", "3006789154", "3007475226", "7682", "3005580113", "3003790304", "3007710604", "2523865", "3006546082", "3003922255", "3015139943", "1216677", "3033010858", "3024021261", "3015309643", "1820334", "3015316279", "3008185830", "3005969827", "3000279801", "3002808273", "3033902430", "3007699067", "3012797688", "3002808148", "3008397795", "3007130719", "3006554912", "3006950086", "3005947796", "3002808001", "3002808268", "3014615697", "3003990090", "3029929134", "3010314836", "3002806359", "3012536737", "1000080301", "3017367014", "3027454635", "3010400865", "3014342096", "1219930", "3003094851", "3000280067", "1000514656", "3000204191", "3029981244", "3010220595", "2020550", "3012375451", "1519132", "3002807072", "3003782610", "3005382983", "3015042209", "1418479", "3015972753", "3002807795", "3942", "1221826", "3008837339", "3013557562", "2183744" ], "device_name": "Cystoscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }