Hobbs Medical is issuing a voluntary recall notification in the United States only for regulatory nonconformance on our Bronchial Cytology Brushes shipped in 2018. The Product Codes are 4202, 4204, and 4206.
Hobbs failed to include the correct FDA product code on the original 510k submission in 1983; as a result these devices have not been officially approved for pulmonary/bronchial marketing by FDA. Hobbs is working to resolve the issue.
Please note that this regulatory non-conformance does not pose a risk to either the patient or the user; to wit: we have sold more than 100,000 units of these products during a 34-year timespan without any patient injuries to our knowledge and with no Medical Device Reports filed with Bronchial Cytology Brushes.
For more information on this voluntary recall, please call 800-344-6227