{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167657", "product_res_number": "Z-0804-2019", "event_date_initiated": "2018-10-17", "event_date_created": "2019-02-06", "recall_status": "Open, Classified", "res_event_number": "81169", "product_code": "KTI", "product_description": "Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation.", "code_info": "All lot numbers manufactured from October 30, 2006 to August 15, 2018, with affected Product and Lot Numbers distributed worldwide - Product Number (Lot Numbers):  825200641 (1271924, 1074548, 1186516, 1364805, 1262505, 1269165, 1313148, 1296901, 1330427, 1382941, 1321674, 1339578, 1265501, 1344236,  1261415, 1372437, 1353961, M054680, M118520, 1003492, 1058979, 1287750);   825200842 (1189516, 1074551, 1319855, 1298913, 1057370, M054700, M118540);   825201041 (1269824, 1277860, 1186520, 1195261, 1230705, 1340401, 1253661, 1263078, 1288520, 1186520 , 1227431, 1368550, 1376018, 1382289, 1316167, 1104163, 1074553, 1307329, 1296285, 1332473, 1319856, 1053400, 1337541, M054720, M118550);   825201241 (1185831, 1372500, 1364881, 1238365, 1273017, 1302457, 1298771, 1186521, 1269168, 1183846, 1323532, 1074555, 1316169, 1344797,  1333774, 1057371, 1361470, 1265502, 1289744, M054730, M118560);   825201441 (1185832, 1189518, 1339287, 1274102, 1281289, 1320136, 1314041, 1360269, 1328548, 1003493, 1074556, M054740, M112910);   825210830 (1264551, 1313443, 1338468, 1212278, 1262656, 1271357, 1320727);   825211030 (1271954, 1293167, 1287813, 1313444, 1265025, 1320728, 1212279, 1342362);   825211230 (1240940, 1253421, 1245260);   825211430 (1253422, 1240941);   825200841 (1274105, 1185829, 1281667, 1257138, 1368638, 1306948, 1265989, 1296284, 1298436, 1189515, 1269820, 1319630, 1376097, 1362251, 1323968, 1107980, 1333771, 1261416, 1378166, 1053398, 1338467, 1288856, 1074550, M054690, M118530, 1241165, 1243611, 1248730, 1253658, 1262506);   Affected Part and Lot numbers distributed Nationwide - Part Number (Lot Numbers):  82520.0641 (1058979, 1074548, 1339578, 1003492, 1313148, M054680, 1186516, 1271924, 1262505, 1269165, 1296901, 1364805, 1330427, 1344236,  M118520, 1287750, 1353961, 1382941);   82520.0841 (1074550, 1333771, 1323968, M054690, 1281667, 1274105, 1241165, 1053398, 1269820, 1243611, 1248730, 1262506, 1288856, 1298436, M118530, 1362251, 1185829, 1198515, 1338467, 1378166, 1253658, 1296284);   82520.0842 (M118540, M054700, 1189516, 1319855);   82520.1041 (1074553, 1319856, 1316167, 1277860, M054720, 1053400, 1269824, 1230705, 1253661, 1263078, 1376018, 1288520, 1332473, M118550, 1337541, 1186520, 1195261, 1382289);   82520.1241 (1074555, 1333774, 1302457, 1057371, M054730, 1269168, M118560, 1238365, 1186521, 1289744, 1372500, 1298771, 1344797, 1361470, 1265502, 1185831);   82520.1441 (1074556, 1320136, 1003493, 1314041, 1281289, M054740,  M112910, 1189518, 1360269, 1274102, 1339287, 1328548);   825210830 (1271357, 1313443, 1212278, 1262656, 1320727, 1264551, 1338468);   825211030 (1320728, 1313444, 1212279, 1265025, 1342362, 1293167, 1287813);   825211230 (1245260, 1253421, 1240940);   825211430 (1240941, 1253422)", "firm_fei_number": "3002808001", "recalling_firm": "Richard Wolf GmbH", "address_1": "Pforzheimer Str. 32 32 pforzheimer str.", "city": "Knittlingen", "country": "Germany", "reason_for_recall": "There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen.", "root_cause_description": "Process control", "action": "On about 09/24/2018, Richard Wolf GmbH sent Urgent Safety Information notices to international consignees. Customers in the USA were sent the \"Urgent Safety Information\" notice on about 10/17/2018. Customers were instructed to check current stock on hand for affected Bronchoscope Tubes, complete and return the attached response form, ensure all appropriate personnel at the facility are notified of the recall, ensure the recall information is observed in your respective institution until all internal measures have been completed, notify Richard Wolf of any adverse events, and return all affected devices included in the recall.\n\nRichard Wolf GmbH expanded the recall and notified customers worldwide on about 12/06/2018 via \"Urgent Safety Information\" notice. Instructions included to check current stock on hand for affected product and lot number, return affected products to Richard Wolf GmbH, notify customers if affected product was further distributed, ensure the recall notification is observed in each customer location, and complete and return the Answer Form provided. \n\nRichard Wolf Medical Instruments (US Distributor) notified customers on about 12/14/2018 via \"Urgent Safety Information: Recall Expansion\" notice. Instructions included to check current stock on hand for affected product and lot number, return affected products to Richard Wolf Medical Instruments, notify customers if affected product was further distributed, ensure the recall notification is observed in each customer location, and complete and return the Answer Form provided.", "product_quantity": "873 units worldwide (468 units within the US)", "distribution_pattern": "Worldwide distribution - US Nationwide in the states of PA, MD, NY, and countries of Bangladesh, Canada, China, France, Germany, India, Italy, Jordan, Netherlands, Poland, Russia, Spain, Thailand, Turkey.", "openfda": { "k_number": [ "K211894", "K181193", "K251664", "K153484", "K230280", "K261274", "K833491", "K171232", "K150951", "K161392", "K193517", "K151522", "K190239", "K251478", "K090660", "K163469", "K241679", "K252874", "K170759", "K250263", "K230778", "K254040", "K213434", "K110218", "K231818", "K023337", "K152922", "K221206", "K781365", "K222187", "K213060", "K082174", "K020765", "K251402" ], "device_name": "Bronchoscope Accessory", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4680", "device_class": "2", "registration_number": [ "1223925", "3015225571", "1043729", "3042970803", "3013023255", "1047843", "3013557562", "3013152301", "3008058134", "3008040402", "3013517171", "3008087383", "1320894", "3006950086", "3007305485", "3003790304", "1820334", "3016548968", "3012536737", "3012042439", "3003418325", "3012494290", "9616684", "3033589330", "3010273872", "3012422952", "3004837686", "3012266672", "3021230784", "3008797804", "9710524", "9681260", "3002907620", "2183744", "3010188783", "3005803389", "8010047", "3014769442", "3002807314", "3013440400", "2183446", "3026787544", "9611102", "1018470", "8040233", "3003477135", "1721676", "9614641", "3007695959", "3015309643", "1651395", "1220477", "3005099803", "3003678543", "1000121056", "3014579161", "3015980719", "3005423519", "3015970743", "1928237", "3005172759", "3011050570", "3014749926", "1724474", "1721504" ], "fei_number": [ "3015225571", "1043729", "3042970803", "3013023255", "1047843", "3013557562", "3013152301", "3008058134", "3008040402", "3013517171", "3008087383", "3003012447", "3006950086", "3007305485", "3003790304", "1820334", "3016548968", "3012536737", "3012042439", "3003418325", "3012494290", "1000305720", "3033589330", "3010273872", "3012422952", "3004837686", "3006165545", "3012266672", "3021230784", "3008797804", "3002807795", "3002907620", "2183744", "3010188783", "3005803389", "3014769442", "3002807314", "3013440400", "2183446", "3026787544", "1018470", "3003477135", "3003995201", "3003094851", "1721676", "3007695959", "3003499455", "3015309643", "3001451571", "1220477", "3005099803", "3002806565", "1000121056", "3014579161", "3015980719", "3003678543", "3015970743", "1928237", "3005172759", "3002808001", "3011050570", "3014749926", "3003944071", "1721504", "3002913962" ] } } ] }