Class II — Hobbs Medical, Inc.
| Recalling firm | Hobbs Medical Inc |
|---|---|
| Registered facility | HOBBS MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | 1820 devices |
| Distribution | US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA. |
| Initiated | 2018-05-01 |
| Classified | 2018-06-01 |
| Terminated | 2020-04-10 |
| Recall number | Z-2052-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hobbs Medical, Inc. (Z-2052-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79903/
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