PENTAX CS6021SNRecalls & reported problems
Hoya Corporation · Cleaning Brush for Endoscope Channel · Class 2
All models of PENTAX (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333063932), received between Sep 11, 2024 and Sep 11, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2024Product Quality Problem; Product Quality Problem
BRUSH OVAL CUT AT THE FRONT INSTEAD OF ROUND AS BEFORE. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20197007 ↗
Other Endoscopic ultrasound system, gastroenterology-urology devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology5 deaths2,392 reports
- PENTAX Medical EG38-J10UTHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology295 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology266 reports
- PENTAX EG-3870UTKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology164 reports
- PENTAX Medical EG36-J10URHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology126 reports
- PENTAX EG-3670URKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology72 reports
- PENTAX Medical EG34-J10UHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology61 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology29 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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