PENTAX Medical EG34-J10U (UDI 04961333248858)Recalls & reported problems
Hoya Corporation · PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U (Made in Malaysia) · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333248858), received between Sep 12, 2024 and Jul 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
- Detachment of Device or Device Component1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50079008 ↗MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22847033 ↗MalfunctionSep 12, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
B3:NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. BASED ON THE INITIAL REPORT, 3 NEW EUS SCOPES HAVE EXPIRED BALLOONS IN THEIR BOX. DESCRIPTION OF ANY ACTIONS TAKEN: SUBMITTED REQUEST TO MAKE SURE WHEN EUS SCOPES ARE SENT OUT, BALLOONS ARE NOT EXPIRED. THIS EVENT OCCURRED AT THE TIME OF DURING INSTALLATION. 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 20208592 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page