OLYMPUS OFP-2 (ROW)Recalls & reported problems
Keymed (Medical & Industrial Equipment) Limited · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus OFP-2 flushing pump supplies water for flushing endoscopes during procedures. Many of its 286 reports describe poor or failed water flow, buttons that stop responding and pumps that break. The reports include 3 injuries and no deaths. No recalls name this device. Reports fell from 62 in the previous 12 months to 34 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 296
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 296 adverse event reports that list this exact device (DI 15019778003238), received between Apr 5, 2022 and Sep 29, 2026 — classified as 3 injuries, 293 malfunctions.
The most frequently reported specific device problem is “Pumping Problem” (62 reports).
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
- Pumping Problem62
- Key or Button Unresponsive/not Working40
- Failure to Pump39
- Break37
- Infusion or Flow Problem20
- Mechanical Problem13
- Insufficient Flow or Under Infusion11
- Improper Flow or Infusion9
Patient problems
- No Clinical Signs, Symptoms or Conditions292
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Laceration(s)1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 296 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938877 ↗MalfunctionSep 21, 2026Pressure Problem
The customer reported abnormal pump head pressure during inspection for use involving an Olympus Flushing Pump. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840762 ↗MalfunctionSep 17, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811915 ↗MalfunctionSep 11, 2026Restricted Flow rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736567 ↗MalfunctionSep 10, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723429 ↗MalfunctionAug 17, 2026Pumping Problem
No additional information received from customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286958 ↗MalfunctionAug 12, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222078 ↗MalfunctionAug 5, 2026Improper Flow or Infusion
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50141032 ↗MalfunctionJul 31, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50104105 ↗MalfunctionJul 30, 2026Failure to Pump
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087032 ↗MalfunctionJul 27, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50018737 ↗MalfunctionMay 21, 2026Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP EXHIBITED HIGH WATER JET SPEED. THE ISSUE WAS IDENTIFIED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240598 ↗MalfunctionMay 11, 2026Improper Flow or Infusion
THE CUSTOMER REPORTED THAT AFTER THE PUMP WAS REPLACED, THE WATER SUPPLY CONTINUED AFTER RELEASING THE FOOT SWITCH DURING SET-UP INVOLVING AN OLYMPUS FLUSHING PUMP. THE CUSTOMER SUSPECTED NO PROBABLE CAUSE OF THE CONTINUOUS WATER SUPPLY. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135229 ↗MalfunctionApr 10, 2026Pumping Problem
IT WAS REPORTED THE WATER SUPPLY OF THE OLYMPUS FLUSHING PUMP WAS NOT GOOD. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845706 ↗MalfunctionApr 10, 2026Pumping Problem
IT WAS REPORTED THE WATER DELIVERY OF THE OLYMPUS FLUSHING PUMP WAS NOT GOOD. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845688 ↗MalfunctionApr 10, 2026Pumping Problem
IT WAS REPORTED THE WATER SUPPLY OF THE OLYMPUS FLUSHING PUMP WAS NOT GOOD. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845485 ↗MalfunctionApr 9, 2026Infusion or Flow Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831268 ↗MalfunctionApr 7, 2026Improper Flow or Infusion
IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP HAD A WATER JET THAT WAS OUT OF ORDER. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802759 ↗MalfunctionApr 3, 2026Infusion or Flow Problem
NO ADDITIONAL INFORMATION WAS PROVIDED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778438 ↗MalfunctionMar 30, 2026Infusion or Flow Problem; Pumping Problem
IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP WAS FOUND TO HAVE A FLOW RATE OUTSIDE THE STANDARD RANGE DURING PRE-USE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716286 ↗MalfunctionMar 4, 2026Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24514591 ↗MalfunctionFeb 26, 2026Pumping Problem
IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP COVER WILL FLIP OPEN WHEN WATER WAS FEEDING. THE EVENT HAD OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461526 ↗MalfunctionFeb 9, 2026Pumping Problem
IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP HAD INTERMITTENT PUMP FUNCTION NOT OPERATING. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292862 ↗MalfunctionFeb 9, 2026Connection Problem
IT WAS REPORTED THAT FLUSHING PUMP HAD WEAK CONNECTION AT PUMP HEAD TUBE CONNECTION. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291422 ↗MalfunctionFeb 5, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE FLUSHING PUMP HAD BEEN UNABLE TO SET DESIRED FLOW RATE. THE ISSUE WAS IDENTIFIED DURING DEVICE INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268861 ↗
Other Pump, Air, Non-Manual, For Endoscope devices
- Olympus MAJ-1651Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope125 reports
- Olympus WB991046OLYMPUS Winter & Ibe GmbH · Pump, Air, Non-Manual, For Endoscope81 reports
- ERBEFLO CleverCap® 20325-239Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall24 reports
- OLYMPUS OFP-2 (US)Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope1 recall22 reports
- ERBEFLO CleverCap® 20325-206Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall5 reports
- ERBEFLO CleverCap® 20325-240Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall3 reports
- ERBEFLO CleverCap® 20325-248Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall3 reports
- ERBEFLO CleverCap® 20325-208Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall1 report
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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