FDA Device recall Z-0711-2022
Bronchial Microbiology Brush, Catalog Number 4310 and 4320
- FDA Device
- Class II
- ongoing
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of Bronchial Microbiology Brush, Catalog Number 4310 and 4320 by Hobbs Medical, citing the labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0711-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-28 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hobbs Medical |
| Distribution | US |
Product
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.
Reason
The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
Identifiers
| code_info | Affected lots were distributed in the United States from 1/18/2017 to 8/26/2021. These lots have expiration dates of 1/…Affected lots were distributed in the United States from 1/18/2017 to 8/26/2021. These lots have expiration dates of 1/01/2022 through 12/01/2026. Catalog Number 4310, Package DI M84943100, Package DI Number M84943101; Catalog Number 4320, Package DI M84943200, Package DI Number M84943201; Lot Numbers: H12-16-112 H12-16-113 H12-16-114 H01-17-002 H01-17-003 H01-17-004 H01-17-005 H01-17-101 H01-17-134 H01-17-135 H01-17-136 H02-17-044 H02-17-045 H02-17-046 H02-17-047 H02-17-048 H03-17-113 H03-17-114 H03-17-115 H03-17-116 H03-17-117 H03-17-233 H03-17-234 H03-17-235 H03-17-236 H03-17-237 H03-17-238 H05-17-119 H05-17-120 H05-17-121 H05-17-122 H05-17-123 H05-17-124 H06-17-142 H06-17-143 H06-17-144 H06-17-145 H07-17-112 H07-17-113 H07-17-114 H07-17-115 H08-17-127 H08-17-128 H08-17-129 H08-17-130 H08-17-131 H08-17-269 H08-17-270 H08-17-271 H08-17-272 H08-17-273 H09-17-102 H09-17-103 H09-17-104 H10-17-053 H10-17-056 H10-17-057 H10-17-058 H10-17-059 H10-17-060 H10-17-061 H11-17-146 H11-17-147 H |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0711-2022%22
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