ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCR (REF N2654442)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170465963), received between Nov 5, 2025 and Feb 25, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Increase in Pressure” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Increase in Pressure1
- Pressure Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Pressure Problem
IT WAS REPORTED THAT THE CO2 REGULATION UNIT HAD DEFECTIVE REGULATION OF THE PRESSURE. IT GOES FROM LOW TO REALLY HIGH. THE ISSUE WAS FOUND DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24445744 ↗MalfunctionNov 5, 2025Increase in Pressure; Increase in Pressure
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476260 ↗
Other Insufflator, Automatic Carbon-Dioxide For Endoscope devices
- HIGH FLOW INSUFFLATION UNIT UHI-4Olympus Medical Systems Corp. · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE3 recalls6 deaths2,484 reports
- ENDOFLATOR UI500Karl Storz GmbH & Co. KG · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE193 reports
- HIGH FLOW INSUFFLATION UNIT UHI-4Olympus Medical Systems Corp. · Insufflator, Automatic Carbon-Dioxide For Endoscope1 recall9 reports
- ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCROlympus Medical Systems Corp. · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE52 reports
- ENDOFLATOR UI400Karl Storz GmbH & Co. KG · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE40 reports
- ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCROlympus Medical Systems Corp. · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE16 reports
- CO2MPACT 710300US Endoscopy · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE4 reports
- ENDO STRATUS CO2 Insufflator EGA-501Medivators Inc. · Insufflator, Automatic Carbon-Dioxide For Endoscope2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.