Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior ...
FDA Device Recall #Z-0804-2019 — Class II — October 17, 2018
Recall Summary
| Recall Number | Z-0804-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 17, 2018 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Richard Wolf GmbH |
| Location | Knittlingen |
| Product Type | Devices |
| Quantity | 873 units worldwide (468 units within the US) |
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.
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.
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.
Lot / Code Information
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)
Other Recalls from Richard Wolf GmbH
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1753-2025 | Class II | PiezoWave 2 Control Unit, Product Number 100506... | Apr 9, 2025 |
| Z-1423-2023 | Class II | FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Numb... | Mar 24, 2023 |
| Z-1422-2023 | Class II | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Numb... | Mar 24, 2023 |
| Z-1425-2023 | Class II | FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Nu... | Mar 24, 2023 |
| Z-1424-2023 | Class II | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Numb... | Mar 24, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.