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 tube

Recall Insight

This FDA Devices action (record #Z-0804-2019) was formally reported on February 13, 2019, with the manufacturer initiating the action on October 17, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. Richard Wolf GmbH is listed as the recalling firm, operating out of Knittlingen. Federal records indicate 873 units worldwide (468 units within the US) units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: 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 data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.