CONNECTING TUBE MAJ-2112Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of CONNECTING TUBE (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus connecting tube is an accessory used to clean endoscopes. Its 143 reports mostly describe the tube breaking, detaching or failing to connect during cleaning, and none describe patient harm. There are no deaths and no injuries. 1 recall names this device, still open, which began in March 2026 over lock levers on a version 2 cleaning-machine tube that may fail early. Reports fell to 0 in the last 12 months from 5 before.
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
- 143
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 04953170404078), received between Mar 15, 2022 and Oct 17, 2025 — classified as 143 malfunctions.
The most frequently reported specific device problem is “Break” (58 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K190969); they may or may not involve this specific model.
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
Recalls naming this device
- Mar 25, 2026Class IIOpen, Classified
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Z-1900-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break58
- Connection Problem52
- Detachment of Device or Device Component13
- Disconnection9
- Fracture8
- Crack2
- Device Reprocessing Problem2
- Material Disintegration2
Patient problems
- No Clinical Signs, Symptoms or Conditions143
Recent adverse event reports
The 25 most recent of 143 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2025Degraded; Degraded
IT WAS REPORTED THAT THE CONNECTING TUBE WAS DEFECTIVE AND BECAME DISCONNECTED DURING THE ALCOHOL FLUSH PHASE OF THE REPROCESSING CYCLE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23327988 ↗MalfunctionFeb 26, 2025Material Disintegration; Material Disintegration
IT WAS REPORTED THAT DURING REPROCESSING THE CONNECTING TUBE WAS FOUND TO BE FADED AND SHOWED A WEAKING OF THE PLASTIC WITH SMALL CRACKS ALONG THE CONNECTOR AND THE WING TIP WAS COMPLETELY BROKEN OFF. THE DEVICE WAS NOT USED DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21471228 ↗MalfunctionFeb 24, 2025Break; Break
IT WAS REPORTED THAT THE CONNECTING TUBE EXHIBITED BROKEN TUBE CLIPS. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446356 ↗MalfunctionJan 10, 2025Break; Break
NO CHANGE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21131885 ↗MalfunctionNov 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CONNECTING TUBE OF THE SUBJECT DEVICE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20732973 ↗MalfunctionOct 23, 2024Break; Break
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE CONNECTING TUBE EXHIBITED ONE OF THE LOCK LEVERS WAS MISSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20519321 ↗MalfunctionOct 23, 2024Break; Break
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE CONNECTING TUBE EXHIBITED BOTH OF THE LOCK LEVERS WERE MISSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20519282 ↗MalfunctionOct 23, 2024Break; Break
IT WAS REPORTED THAT THE SUCTION CONNECTOR AND THE AUXILIARY WATER CONNECTOR WERE BROKEN FOR NO REASON. CONSEQUENTLY, THERE WAS CANCELLATION OF ALL PROCEDURES ON BECAUSE THE FACILITY COULD NOT REPROCESS THE SCOPES. THE ISSUE OCCURRED DURING REPROCESSING WITH NO EVIDENCE OF DIRECT PATIENT INVOLVEMENT. THOUGH PROCEDURES WERE CANCELLED, THERE WAS NO INDICATION THAT THESE WERE BEING DONE URGENTLY OR EMERGENTLY FOR LIFE-THREATENING REASONS OR THAT THE CANCELLATION OF SAID PROCEDURES CAUSED ANY LIFE-THREATENING COMPLICATIONS OR HEALTH CONDITIONS. AT THIS TIME, THERE IS NO EVIDENCE THAT A LIFE-THREATENING EVENT OCCURRED, THAT A PATIENT HAS DEVELOPED A PERMANENT DISABILITY OR PERMANENT DAMAGE THAT CAUSED SUBSTANTIAL DISRUPTION IN THEIR ABILITY TO CONDUCT NORMAL LIFE FUNCTIONS, OR THAT ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE THAT IS SUSPECTED TO BE DUE TO THE USE OF THE OLYMPUS DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517425 ↗MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE CONNECTING TUBE SET CLAMP COMES APART AND PULLS OFF. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20412288 ↗MalfunctionOct 9, 2024Material Disintegration; Material Disintegration
IT WAS REPORTED THE CONNECTING TUBE WAS FADED AND SHOWED A WEAKING OF THE PLASTIC WITH SMALL CRACKS ALONG THE CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410835 ↗MalfunctionOct 9, 2024Break; Break
THE CUSTOMER REPORTED THAT SHE HAS BEEN EXPERIENCING A CONSISTENT PROBLEM WITH THE OLYMPUS CONNECTING TUBES. ACCORDING TO THE INITIAL REPORTER, THE CLIP COMPONENT IS VERY FRAGILE AND BREAKS EASILY. REPORTEDLY, 1-2 OF THESE PLASTIC CLIPS THAT HOLD THE CONNECTING TUBES TO THE REPROCESSOR ARE BREAKING EACH MONTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20407890 ↗MalfunctionSep 25, 2024Break; Disconnection; Break; Disconnection
IT WAS REPORTED, THE ENDOSCOPE REPROCESSOR ACCESSORIES CONNECTING TUBE ON THE REPROCESSER ARE BREAKING AND POPPING OFF MID CYCLE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20303795 ↗MalfunctionSep 25, 2024Break; Disconnection; Break; Disconnection
IT WAS REPORTED, THE ENDOSCOPE REPROCESSOR ACCESSORIES CONNECTING TUBE ON THE REPROCESSER ARE BREAKING AND POPPING OFF MID CYCLE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20303636 ↗MalfunctionSep 25, 2024Break; Disconnection; Break; Disconnection
IT WAS REPORTED, THE ENDOSCOPE REPROCESSOR ACCESSORIES CONNECTING TUBE ON THE REPROCESSER ARE BREAKING AND POPPING OFF MID CYCLE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20303248 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTOR ON THE CONNECTING TUBE WAS BROKEN. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND, AND NO PROCEDURAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20225475 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTOR ON THE CONNECTING TUBE WAS BROKEN. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND, AND NO PROCEDURAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20225426 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTOR ON THE CONNECTING TUBE WAS BROKEN. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND, AND NO PROCEDURAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20225398 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTOR ON THE CONNECTING TUBE WAS BROKEN. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND, AND NO PROCEDURAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20225375 ↗MalfunctionSep 8, 2024Disconnection; Disconnection
IT WAS REPORTED THE ENDOSCOPE REPROCESSOR CONNECTING TUBE ¿S CONNECTORS ARE POPPING OFF/DISCONNECTING MID CYCLE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20166429 ↗MalfunctionAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THE CONNECTING TUBE COULD NOT CONNECT TO THE CHANNEL CONNECTOR. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20016845 ↗MalfunctionAug 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THE CONNECTING TUBE COULD NOT CONNECT TO THE CHANNEL CONNECTOR. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19999647 ↗MalfunctionAug 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CONNECTING TUBE CANNOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19992057 ↗MalfunctionAug 14, 2024Break; Break
THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19987538 ↗MalfunctionJul 25, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE CONNECTING TUBE COULD NOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19833502 ↗MalfunctionJul 25, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE CONNECTING TUBE COULD NOT BE CONNECTED TO THE CHANNEL CONNECTOR IN THE REPROCESSING BASIN. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19833493 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K190969. One submission often covers many models, so check the product and lot details in each record.
- Z-0638-2022 · Dec 13, 2021 · TerminatedOER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessor
Other Accessories, Cleaning, For Endoscope devices
- ENDOSCOPE REPROCESSOR OER-ProOlympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE3 recalls1,163 reports
- ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · Accessories, cleaning, for endoscope4 recalls323 reports
- SINGLE USE DISTAL COVER MAJ-2315Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls294 reports
- CONNECTING TUBE MAJ-2110Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall213 reports
- CONNECTING TUBE MAJ-2111Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall164 reports
- CONNECTING TUBE MAJ-2113Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall159 reports
- ENDOSCOPE REPROCESSOR OER-MINIOlympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls11 reports
- Medivators HookupMedivators Inc. · Accessories, cleaning, for endoscope2 recalls0 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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