Hobbs Medical recalls bronchial cytology brushes (models 4202, 4204, 4206) that were marketed for uses outside FDA clearance. These brushes are intended for trained medical professionals during endoscopic procedures.
Device was marketed for uses outside the 510(k) clearance.
Hobbs Medical is recalling bronchial cytology brushes (models 4202, 4204, 4206) because they were sold for uses not approved by the FDA. This means the brushes could be used incorrectly, potentially leading to unsafe medical procedures.
The brushes were marketed for medical use without proper FDA clearance for their intended purpose. This could lead to improper sample collection or other complications during endoscopic procedures if used outside approved guidelines.
Trained medical professionals who use these brushes during endoscopic procedures are most likely affected. Patients receiving these procedures may be at risk if the brushes are used improperly.
Check for model numbers 4202, 4204, or 4206 on the brush packaging. These brushes are intended for use by trained medical personnel through flexible endoscopes for cytological analysis.
Identify the model number on the brush packaging to confirm if it is 4202, 4204, or 4206.
The recall states the brushes were marketed for uses outside FDA clearance, but they are intended for trained medical professionals during endoscopic procedures. The official notice does not specify if they are safe for use.
The recall does not provide a remedy, so the official notice does not specify any action steps for affected users.
The recall does not indicate a need to stop using them, but the brushes were marketed for unapproved uses, which could lead to complications if used incorrectly.
We’ve drafted a message you can send Hobbs Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2052-2018 — Hobbs Medical Hobbs Medical Hello, I own a Hobbs Medical that is covered by recall Z-2052-2018 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.
