{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "30445", "product_res_number": "Z-0248-04", "event_date_initiated": "2003-10-10", "event_date_posted": "2003-12-18", "recall_status": "Terminated", "event_date_terminated": "2016-01-28", "res_event_number": "27738", "product_code": "FEM", "product_description": "Smith & Nephew Endocoupler C-Mount 35 mm Focal Length\nReference :7204614 and 7204614S (S indicates unit previously serviced)", "code_info": "Number: 7204614, Camera Coupler, C-Mount, 35mm F.L. Serial Numbers (QW prefix):   15601\t16920\t16981\t18031\t18066\t18111\t18143\t18276\t18354 15603\t16924\t16982\t18032\t18067\t18112\t18147\t18278\t18355 15604\t16927\t16983\t18033\t18068\t18113\t18149\t18282\t18358 15605\t16932\t16985\t18035\t18069\t18114\t18157\t18283\t18359 15607\t16933\t16987\t18036\t18070\t18116\t18158\t18284\t18362 15606\t16935\t16988\t18039\t18071\t18118\t18168\t18288\t18363 15609\t16936\t16989\t18040\t18072\t18119\t18169\t18289\t18370 15612\t16950\t16990\t18041\t18073\t18120\t18177\t18291\t18382 15617\t16951\t16991\t18042\t18074\t18121\t18187\t18292\t18391 15622\t16957\t16992\t18043\t18075\t18122\t18188\t18295\t18399 15623\t16958\t16993\t18044\t18076\t18123\t18189\t18296\t18445 15626\t16961\t16994\t18045\t18077\t18125\t18198\t18300\t18460 15630\t16962\t17005\t18046\t18078\t18126\t18199\t18301\t18461 16697\t16964\t17006\t18047\t18079\t18127\t18200\t18303\t18462 16713\t16965\t17025\t18048\t18080\t18128\t18201\t18304\t18464 16719\t16966\t17029\t18049\t18084\t18129\t18203\t18306\t18469 16720\t16967\t17030\t18050\t18088\t18130\t18204\t18307\t18470 16722\t16968\t17045\t18051\t18093\t18131\t18205\t18308\t18471 16726\t16969\t17050\t18052\t18097\t18132\t18206\t18309\t18476 16729\t16970\t17052\t18053\t18098\t18133\t18207\t18310\t18477 16797\t16971\t17068\t18054\t18100\t18134\t18209\t18315\t18478 16891\t16972\t17069\t18055\t18101\t18135\t18210\t18325\t18479 16897\t16973\t17092\t18056\t18102\t18136\t18212\t18326\t18480 16898\t16974\t17100\t18057\t18103\t18137\t18219\t18336\t 16899\t16975\t18000\t18059\t18104\t18138\t18239\t18342\t 16907\t16976\t18001\t18060\t18105\t18139\t18258\t18346\t 16914\t16977\t18024\t18062\t18107\t18140\t18266\t18351\t 16915\t16978\t18029\t18063\t18108\t18141\t18269\t18352\t 16916\t16980\t18030\t18064\t18110\t18142\t18275\t18353\t  Part Number: 7204614S, Camera Coupler, C-Mount, 35mm F.L. Serial Numbers (QW prefix): 18034\t18096\t18160\t18259\t18297\t18383\t18416\t18434\t18453 18038\t18099\t18161\t18260\t18313\t18384\t18417\t18435\t18454 18058\t18106\t18162\t18261\t18314\t18385\t18418\t18436\t18455 18061\t18109\t18163\t18262\t18316\t18386\t18419\t18437\t18456 18065\t18115\t18164\t18263\t18323\t18393\t18420\t18438\t18457 18081\t18144\t18165\t18264\t18324\t18394\t18421\t18439\t18458 18082\t18145\t18166\t18267\t18333\t18395\t18422\t18440\t18459 18083\t18146\t18167\t18270\t18334\t18402\t18423\t18441\t18463 18085\t18148\t18170\t18272\t18335\t18403\t18424\t18442\t18465 18086\t18150\t18171\t18273\t18344\t18404\t18425\t18443\t18466 18087\t18151\t18172\t18274\t18345\t18405\t18426\t18444\t18467 18089\t18152\t18231\t18277\t18356\t18408\t18427\t18446\t18472 18090\t18153\t18232\t18279\t18364\t18411\t18428\t18447\t18473 18091\t18154\t18246\t18285\t18366\t18412\t18429\t18448\t18474 18092\t18155\t18250\t18287\t18373\t18413\t18430\t18450\t18475 18094\t18156\t18256\t18293\t18374\t18414\t18431\t18451\t 18095\t18159\t18257\t18294\t18376\t18415\t18433\t18452", "firm_fei_number": "3003604053", "recalling_firm": "Smith And Nephew, Inc. Endoscopy Division", "address_1": "150 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1031", "additional_info_contact": "Jason Bilobram\n978-474-6332", "reason_for_recall": "Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.", "root_cause_description": "Nonconforming Material/Component", "action": "Smith & Nephew notified direct accounts by letter on 10/15/03. Service representatives will remove and replace product.", "product_quantity": "255 units", "distribution_pattern": "Nationwide to hospitals\nForeign: Australia, Africa, Belgium, Canada, China, Dubai, Egypt, Germany, D\\Godmanchester, Italy, Japan, Korea, Malaysia, Norway, Portugal, Singapore, South Africa, Thailand, Taiwan.", "openfda": { "k_number": [ "K792512", "K812201", "K812542", "K940152" ], "device_name": "Accessories, Photographic, For Endoscope (Exclude Light Sources)", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "1", "registration_number": [ "3010331645", "8030607", "9611102", "1225968", "3011459664", "1833053", "3001644167", "9614209", "3003782610", "1221934", "3012843412", "3021393544", "3042225166", "9611112", "3013831261", "3002808148", "2124215", "1222616", "3019530907", "3021226419", "3004443374", "2085947", "9610612", "3001556604", "3016050940", "1220246", "8043980", "3008953712", "2183911", "2938071", "3010202439", "9610877", "3006161756", "3005099803", "2936485", "9610617", "3021336182", "3015168749", "3010399422", "3003775006", "3012797688", "3012447612", "3027655341", "3012883081", "3014342096", "3033043422", "1017294", "9610691", "3011373951", "3016045249", "1418479", "2027009", "9611174", "3008114965", "1836161", "3030926959", "3019512034", "3008494403", "3034676720", "3014498758", "1222773", "8010047", "3016436764" ], "fei_number": [ "3010331645", "3002750084", "3011459664", "1833053", "3001644167", "3002914049", "3003782610", "1221934", "1000162602", "1000120916", "1000120768", "3012843412", "3021393544", "3042225166", "3013831261", "3002808148", "3007475226", "3000204191", "2124215", "3002808001", "3019530907", "3021226419", "3004443374", "3001556604", "3016050940", "1220246", "3008953712", "2938071", "3002806359", "3002807795", "3005099803", "2936485", "3002480801", "3021336182", "3015168749", "3010399422", "3003775006", "3012797688", "3012447612", "3027655341", "3012883081", "3014342096", "3033043422", "1017294", "3002806315", "3011373951", "3008185830", "3002806725", "1000116142", "3016045249", "3008782585", "2027009", "1418479", "3008114965", "3030926959", "3019512034", "3008494403", "3002808127", "3006509795", "3014498758", "3002808268", "3034676720", "3016436764" ] } } ] }