Richard Wolf Bronchoscope Tubes — Class II medical device recall Z-0804-2019
Ongoing recall by Richard Wolf GmbH, reported 2019-02-13, distributed nationwide. There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding
| Recall number | Z-0804-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Richard Wolf GmbH, Knittlingen, Germany |
| Recall initiated | 2018-10-17 |
| Classified | 2019-02-06 |
| Reported by FDA | 2019-02-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BD, CA, CN, DE, ES, FR, IN, IT, JO, NL, PL, RU, TH, TR |
| Lot numbers | 1003492, 1003493, 1053398, 1053400, 1057370, 1057371, 1058979, 1074548, 1074550, 1074551, 1074553, 1074555, 1074556, 1104163, 1107980, 1183846, 1185829, 1186516, 1186520, 1186521, 1189515, 1189516, 1189518, 1195261, 1198515, 1212278, 1212279, 1227431, 1230705, 1238365, 1241165, 1243611, 1248730, 1253421, 1253658, 1253661, 1257138, 1261415, 1261416, 1262505 and 106 more |
| Model numbers | 1003492, 1003493, 1053398, 1053400, 1057371, 1074548, 1185829, 1186516, 1186520, 1186521, 1189516, 1189518, 1195261, 1198515, 1212278, 1212279, 1230705, 1238365, 1241165, 1243611, 1248730, 1253421, 1253658, 1253661, 1262505 and 74 more |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0804-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.