Hobbs Medical recalls Bronchial Microbiology Brush models 4310 and 4320 due to incorrect labeling for bronchial use. These devices are cleared for gastrointestinal use only, not bronchial.
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.
Hobbs Medical is recalling two types of Microbiology Brush (catalog numbers 4310 and 4320) because they are labeled as bronchial brushes but are only cleared for gastrointestinal use. This mismatch could lead to improper use in the respiratory tract.
The brushes are designed for gastrointestinal sampling, not bronchial. If used for bronchial procedures, the device may break or cause injury due to the spring mechanism being too weak to handle bronchial tissue.
Healthcare professionals who use these brushes for bronchial procedures may have the wrong device. Patients using the brushes for gastrointestinal procedures are likely safe.
Check for catalog numbers 4310 or 4320. These were sold from January 18, 2017, to August 26, 2021, with expiration dates from January 1, 2022, through December 1, 2026.
Look for catalog numbers 4310 or 4320 on the product packaging or device itself.
Ensure the brush is used only for gastrointestinal procedures, not bronchial procedures.
The brushes are labeled as bronchial devices but are only cleared for gastrointestinal use, which could cause injury if used incorrectly.
Check the catalog number. If it's 4310 or 4320, use it only for gastrointestinal procedures to avoid injury.
No, these brushes are not cleared for bronchial use and could break during bronchial procedures, causing injury.
We’ve drafted a message you can send Hobbs Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0711-2022 — Hobbs Medical Hobbs Medical Hello, I own a Hobbs Medical that is covered by recall Z-0711-2022 from Hobbs Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
