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
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 ACCORDING TO THE PHYSICIAN, THEY NOTICED THE TIP HAD FALLEN OFF WHILE INSIDE THE LUNG AND WHEN THE DEVICE WAS RETRACTED FROM THE SCOPE, THERE WAS NO TIP ON THE DEVICE.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, ClassifiedBronchial 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
- RX Cytology Brush M00545000Boston Scientific Corporation · endoscopic cytology brush161 reports
- superDimension AKI00100-01Covidien LP · endoscopic cytology brush5 reports
- CytoMax II G22674Cook Incorporated · endoscopic cytology brush4 reports
- Infinity 00711652US Endoscopy · endoscopic cytology brush4 reports
- superDimension SDNB2000Covidien LP · endoscopic cytology brush1 death3 reports
- CONMED 129RConmed Corporation · endoscopic cytology brush2 reports
- Infinity 00711499US Endoscopy · endoscopic cytology brush2 reports
- Infinity 00711653US Endoscopy · endoscopic cytology brush2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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