Medical device recalls Moderate risk

Hobbs Medical, Inc. recalls Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained pe…

Recall date
May 1, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2052-2018
FDA classification
Class II
Brand / firm
Hobbs Medical, Inc.
Sold / distributed
US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.

Why it was recalled

Device was marketed for uses outside the 510(k) clearance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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