Hobbs Bronchial Cytology Brushes Recalled for Unauthorized Marketing
Hobbs Medical is recalling 1,820 bronchial cytology brushes because they were marketed for uses outside their FDA clearance.
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 no illnesses or injuries were reported and the hazard is related to marketing compliance rather than a direct physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
Hobbs Medical, Inc. is recalling 1,820 units of Hobbs Bronchial Cytology Brushes, Model Numbers 4202, 4204, and 4206. These medical devices are intended to be utilized by trained physicians and personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
The recall was initiated because the devices were marketed for uses outside the scope of their 510(k) clearance. The affected units were distributed nationwide to the states of Arizona, California, Georgia, Illinois, Maryland, New York, Tennessee, Texas, and Virginia.
Hobbs Medical, Inc. is the recalling firm. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the use of these devices.
The recalled product
- 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
- Hobbs Medical, Inc.
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 1,820
Distribution
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