Lower riskMedical device recall · FDA · Published May 1, 2018
Hobbs Bronchial Cytology Brushes Recall: Device Marketed for Unapproved Uses
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.
“Hobbs Bronchial Cytology Brushes Recall: Device Marketed for Unapproved Uses.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71236-hobbs-bronchial-cytology-brushes-recall-device-marketed-for-unapproved-uses. Based on FDA recall #Z-2052-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2052-2018%22&limit=1).
The FDA announced on May 1, 2018, that Hobbs Medical, Inc. is recalling Hobbs Bronchial Cytology Brushes due to marketing for uses outside 510(k) clearance, according to the FDA.
The device was marketed for uses outside the 510(k) clearance, according to the FDA.
Context
GovInfoNow's records show Hobbs Medical, Inc. has 4 other recalls on record since December 28, 2021. Other recent recalls of similar products include Medline Convenience Kits with Unapproved Syringes: Safety Recall (February 27, 2026) and Medline Convenience Kits with Unapproved Syringes Recalled (February 27, 2026).
How to tell if you have this one
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.
Brand
Hobbs Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Model
Identify the model number on the brush packaging to confirm if it is 4202, 4204, or 4206.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Georgia, Illinois, Maryland, New York, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
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.
Official source: FDA Recall #Z-2052-2018 (May 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2052-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.