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Hobbs Microbiology Brush 4310Recalls & reported problems

Hobbs Medical, Inc. · The Hobbs Microbiology Brush is intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil inside a plastic tube, whose distal end is equipped with plastic bristles for harvesting and protecting mucosal cells, e.g., during endoscopy. This is a single-use device. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M84943100), received between Aug 24, 2023 and Sep 26, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K893729); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Material Separation1

Patient problems

  • Foreign Body In Patient1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 26, 2024Material Separation; Material Separation

    IT WAS REPORTED THAT THE DISTAL ATRAUMATIC BALL TIP OF THE MICROBIOLOGY BRUSH FELL OFF WHICH THE DEVICE WAS IN THE PATIENT'S RIGHT UPPER LOBE OF THE LUNG. ACCORDING TO THE PHYSICIAN, THEY NOTICED THE TIP HAD FALLEN OFF WHILE INSIDE THE LUNG AND WHEN THE DEVICE WAS RETRACTED FROM THE SCOPE, THERE WAS NO TIP ON THE DEVICE. PHYSICIAN CONFIRMED THE TIP WAS NOT LODGED IN THE SCOPE AND DID NOT FEEL IT WOULD BE POSSIBLE TO SUCTION THE SEPARATED COMPONENT OUT OF THE LUNG. PHYSICIAN PLANNED TO SEND THE PATIENT FOR SCANS TO IDENTIFY THE LOCATION OF THE TIP IN THE LUNG.

    Patient problems: Foreign Body In Patient

    MAUDE report 20309145 ↗
  • MalfunctionAug 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE INITIAL REPORTER, A MICROBIOLOGY BRUSH WAS USED ON A PATIENT FOR BRONCHOSCOPY. WHILE TAKING THE BRUSH SAMPLE, THE BLUE PLASTIC TEAR DROP TIP ON THE DISTAL END OF THE BRUSH CAME OFF AND FELL INTO THE PATIENT'S BRONCHUS. THE PLASTIC TIP WAS REMOVED WITH SUCTION, AND NO MAJOR DAMAGE WAS VISIBLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17617995 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K893729. One submission often covers many models, so check the product and lot details in each record.

  • Z-0711-2022 · Dec 28, 2021 · Open, Classified
    Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desi

Other Endoscopic Cytology Brush devices

All Endoscopic Cytology Brush devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page