Hobbs Bronchial Cytology Brushes — Class II medical device recall Z-2052-2018
Terminated recall by Hobbs Medical, Inc., reported 2018-06-13, distributed nationwide. Device was marketed for uses outside the 510(k) clearance.
| Recall number | Z-2052-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hobbs Medical, Inc., Stafford Springs, CT, United States |
| Recall initiated | 2018-05-01 |
| Classified | 2018-06-01 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 1,820 devices |
| Model numbers | 4202 |
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.
Reason for recall
Device was marketed for uses outside the 510(k) clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2052-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.