Richard Wolf GmbH: 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.

Recall number

Z-0804-2019

Recalling firm

Richard Wolf GmbH

Product

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.

Status

Open, Classified

Initiated

2018-10-17

Posted

not on file

Terminated

not on file

Reason

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

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. Richard 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. Richard 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.

Quantity

873 units worldwide (468 units within the US)

Distribution

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.

Lot, serial or model codes

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)

510(k) numbers

not on file

PMA numbers

not on file

Product code

KTI

Firm FEI

3002808001

Firm city

Knittlingen

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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