FDA Device recall Z-2052-2018
Hobbs Bronchial Cytology Brushes, Model Number 4202
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of Hobbs Bronchial Cytology Brushes, Model Number 4202 by Hobbs Medical, citing device was marketed for uses outside the 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2052-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-01 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hobbs Medical |
| Distribution | US |
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
Device was marketed for uses outside the 510(k) clearance.
Identifiers
| code_info | H07-17-157 H12-17-004 H10-17-055 H12-17-062 H11-17-101 H12-17-062 H11-17-119 H12-17-064 H11-17-120 H12-17-064…H07-17-157 H12-17-004 H10-17-055 H12-17-062 H11-17-101 H12-17-062 H11-17-119 H12-17-064 H11-17-120 H12-17-064 H11-17-121 H12-17-065 H11-17-122 H12-17-066 H11-17-123 H12-17-067 H11-17-124 H01-18-095 H11-17-125 H01-18-096 H11-17-126 H01-18-097 H11-17-127 H01-18-097 H11-17-128 H01-18-098 H11-17-129 H01-18-098 H11-17-130 H01-18-098 H12-17-002 H01-18-099 H12-17-003 H01-18-100 H12-17-003 H01-18-101 H01-18-102 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2052-2018%22
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