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Lower risk Medical device recall · FDA · Published December 28, 2021

Hobbs Medical Bronchial Microbiology Brush Recall: Not for Bronchial Use

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.

🇺🇸 FDA recall #Z-0711-2022Medical deviceHobbs Medical ›
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Recalling firmHobbs Medical, Inc.8 Spring St · Stafford Springs, CT 06076-1505
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61332-hobbs-medical-bronchial-microbiology-brush-recall-not-for-bronchial-use.

Source Summary by GovInfoNow · govinfonow.com/recall/61332-hobbs-medical-bronchial-microbiology-brush-recall-not-for-bronchial-use · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0711-2022

Cite this page

“Hobbs Medical Bronchial Microbiology Brush Recall: Not for Bronchial Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61332-hobbs-medical-bronchial-microbiology-brush-recall-not-for-bronchial-use. Based on FDA recall #Z-0711-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0711-2022%22&limit=1).

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).

How to tell if you have this one

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.

  • Brand
    Hobbs Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for catalog numbers 4310 or 4320 on the product packaging or device itself.

  2. Verify Use Intended

    Ensure the brush is used only for gastrointestinal procedures, not bronchial procedures.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Dec 28, 202112. FDA classified it Class II: Mar 2, 202223. Published in FDA’s Enforcement Report: Mar 9, 2022320212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-0711-2022 (December 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0711-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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