Endoscopic Cytology Brush
FDA adverse event reports and recall history for endoscopic cytology brush (product code FDX), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 693
- Deaths
- 5
- Injuries
- 107
- Malfunctions
- 576
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2022-10-07Open, ClassifiedProcess control
Hobbs Medical Cytology Brush Catalog Number: 4204
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-07Open, ClassifiedProcess control
Hobbs Medical Cytology Brush Catalog Number: 4206
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-03-02Open, ClassifiedNo Marketing Application
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 desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.
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.
- 2006-11-16TerminatedOther
Lysus Transport Stand (infusion stand), part number 4896-003
Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard.
- TerminatedLabeling False and Misleading
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
Device was marketed for uses outside the 510(k) clearance.
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