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Hobbs Medical, Inc. recalls Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained
Recalled June 13, 2018 · FDA recall Z-2052-2018 · Hobbs Medical
Hazard
Device was marketed for uses outside the 510(k) clearance. · FDA Class II
Units
1820 devices
Sold at
US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
Description
Device was marketed for uses outside the 510(k) clearance.
Product
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
Manufacturer(s)
Hobbs Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →