Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0804-2019·Announced 2019-02-13

Richard Wolf Bronchoscope Tubes Recalled for Potential Bonding Defects

Richard Wolf GmbH is recalling 873 Bronchoscope Tubes, Model Texas, because non-functional bonding points may loosen. The devices are used for respiratory tract investigation and therapy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the defect involves 'non-functionally relevant' bonding points and does not report any injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Richard Wolf GmbH is recalling 873 units of Bronchoscope Tubes, Model Texas, worldwide, including 468 units in the United States. The recall is due to a potential deficiency where non-functionally relevant bonding points or cemented areas of the tubes may loosen.

The affected devices are reusable bronchoscopes intended for the investigation, diagnosis, and therapy of pathological changes in the tracheobronchial respiratory pathways. They are also used for the removal of foreign bodies and to allow the insertion of auxiliary instruments. The recall covers all lot numbers manufactured from October 30, 2006, to August 15, 2018.

The devices were distributed in the US states of Pennsylvania, Maryland, and New York, as well as in Bangladesh, Canada, China, France, Germany, India, Italy, Jordan, the Netherlands, Poland, Russia, Spain, Thailand, and Turkey. Users should stop using the affected devices and contact the manufacturer for instructions on return or replacement.

The recalled product

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…
Manufacturer: Richard Wolf GmbH
Category: Medical Device — Endoscopy
Hazard: structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

All lot numbers manufactured from October 30
2006 to August 15
2018
1074548
1186516
1364805
1262505
1269165
1313148
1296901
1330427
1382941
1321674
1339578
1265501
1344236
1261415
1372437
1353961
M054680

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Same manufacturer · Richard Wolf GmbH

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