Bronchial Microbiology Brush — Class II medical device recall Z-0711-2022
Ongoing recall by Hobbs Medical, Inc., reported 2022-03-09, distributed nationwide. The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is
| Recall number | Z-0711-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hobbs Medical, Inc., Stafford Springs, CT, United States |
| Recall initiated | 2021-12-28 |
| Classified | 2022-03-02 |
| Reported by FDA | 2022-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 38,357 devices |
| Reason classes | microbial contamination, labeling, unapproved product |
| Lot numbers | H01-17-002, H01-17-003, H01-17-004, H01-17-005, H01-17-101, H01-17-134, H01-17-135, H01-17-136, H01-19-023, H01-19-024, H01-19-025, H01-19-026, H01-19-027, H01-19-178, H01-19-179, H01-19-180, H01-19-181, H01-19-182, H01-19-183, H01-19-184, H01-19-185, H01-19-186, H01-19-187, H01-19-188, H01-19-189, H01-19-190, H01-19-191, H01-19-192, H01-19-193, H01-19-194, H01-19-195, H01-19-196, H01-19-197, H01-19-198, H01-20-008, H01-20-009, H01-20-010, H01-20-011, H01-20-012, H01-20-013 and 416 more |
| Model numbers | 4310, 4320 |
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 for recall
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.
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-0711-2022. 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.