The FDA announced on 2021-12-28 that Hobbs Medical, Inc. is recalling Bronchial Microbiology Brushes because the labeling incorrectly identifies them for bronchial use when they are cleared only for gastrointestinal use. The agency issued recall number Z-0711-2022 for the Class II device.
How to tell if you have it
- Brand: Hobbs Medical
- Product: Bronchial Microbiology Brush
- Catalog Numbers: 4310, 4320
- Package DI Numbers: M84943100, M84943101 (Cat. 4310); M84943200, M84943201 (Cat. 4320)
- Lot Codes: H12-16-112 through H07-21-144 (as listed in record)
- Distribution: United States Nationwide from 1/18/2017 to 8/26/2021
- Expiration Dates: 1/01/2022 through 12/01/2026
- Units Affected: 38,357 devices
The hazard
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.
Context
GovInfoNow's records show Hobbs Medical, Inc. has 4 other recalls on record since 2018-05-01. Other recent recalls of similar products include Medline Neuro Pack Kits Contaminated with Bacillus Species (2026-06-11), Medline Airway Exam Kit Recall: Risk of Foreign Body in Airway (2026-02-16), and Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (2026-06-12).