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Lower risk Medical 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.

🇺🇸 FDA recall #Z-2052-2018Medical deviceHobbs Medical ›
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Contact the company

Recalling firmHobbs Medical, Inc.8 Spring St · Stafford Springs, CT 06076-1505
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/71236-hobbs-bronchial-cytology-brushes-recall-device-marketed-for-unapproved-uses.

Source Summary by GovInfoNow · govinfonow.com/recall/71236-hobbs-bronchial-cytology-brushes-recall-device-marketed-for-unapproved-uses · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2052-2018

Cite this page

“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.

How to tell if you have it

  • Brand: Hobbs Medical
  • Product: Hobbs Bronchial Cytology Brushes
  • Model Numbers: 4202; 4204; 4206
  • Lot Codes: H07-17-157, H12-17-004, H10-17-055, H12-17-062, H11-17-101, H12-17-062, H11-17-119, H12-17-064, H11-17-120, H12-17-064, H11-17-121, H12-17-065, H11-17-122, H12-17-066, H11-17-123, H12-17-067, H11-17-124, H01-18-095, H11-17-125, H01-18-096, H11-17-126, H01-18-097, H11-17-127, H01-18-097, H11-17-128, H01-18-098, H11-17-129, H01-18-098, H11-17-130, H01-18-098, H12-17-002, H01-18-099, H12-17-003, H01-18-100, H12-17-003, H01-18-101, H01-18-102
  • Units Affected: 1820 devices

The hazard

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

  1. 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.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

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.

1. Firm started the recall: May 1, 201812. FDA classified it Class II: Jun 1, 201823. Published in FDA’s Enforcement Report: Jun 13, 201834. FDA terminated the recall: Apr 10, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Can I still use these brushes?

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.

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Where this comes from

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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA