Z-0804-2019Class II

Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use

Name: Z-0804-2019 Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use
Creator: Richard Wolf GmbH
Published: 2018-10-17
License: https://open.fda.gov/license/

Richard Wolf GmbH / initiated 2018-10-17 / Open, Classified / root cause: manufacturing process

FDA source

Richard Wolf GmbH began a recall of Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for... on 2018-10-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0804-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-10-17
Posted: 2019-02-06
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.
Product code: KTI Bronchoscope Accessory
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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0804-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0804-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-13	2019-02-06

Product code KTI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)