CONNECTING TUBE MAJ-2110Recalls & 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 endoscope connecting tube has 213 adverse event reports, with no deaths or injuries. The reports describe the tube breaking, cracking or coming loose during cleaning and reprocessing, and no patients were involved. 1 open recall names this device, started in March 2026 because the lock levers on certain reprocessor connecting tubes may fail too early.
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
- 213
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 04953170404054), received between Apr 22, 2022 and Feb 23, 2026 — classified as 213 malfunctions.
The most frequently reported specific device problem is “Break” (128 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-1898-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break128
- Connection Problem40
- Detachment of Device or Device Component16
- Disconnection7
- Degraded6
- Material Split, Cut or Torn5
- Crack4
- Fracture4
Patient problems
- No Clinical Signs, Symptoms or Conditions213
Recent adverse event reports
The 25 most recent of 213 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOSCOPE REPROCESSOR ACESSORIES EXHIBITED DAMAGED TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413081 ↗MalfunctionFeb 20, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOSCOPE REPROCESSOR ACCESSORIES HAD A DAMAGED TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24406300 ↗MalfunctionFeb 20, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CONNECTING TUBE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402578 ↗MalfunctionFeb 17, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOSCOPE REPROCESSOR EXHIBITED A DAMAGED TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366846 ↗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 23327501 ↗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 21446224 ↗MalfunctionFeb 13, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21374847 ↗MalfunctionFeb 12, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE REPROCESSING, THE CONNECTING TUBE EXHIBITED THAT THE LOCKING LEVERS BREAK VERY EASILY, AND THE PLASTIC CRACKS AT THE BASE OF THE FIN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21371148 ↗MalfunctionFeb 12, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21365023 ↗MalfunctionJan 27, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21242211 ↗MalfunctionJan 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CONNECTING TUBE DID NOT HAVE FULL CONNECTION DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21240457 ↗MalfunctionJan 24, 2025Connection Problem; Connection Problem
IT WAS REPORTED THE CONNECTORS DID NOT HAVE FULL CONNECTION DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21230888 ↗MalfunctionJan 24, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21230054 ↗MalfunctionJan 23, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21226475 ↗MalfunctionJan 23, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21225924 ↗MalfunctionJan 23, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21219274 ↗MalfunctionJan 23, 2025Connection Problem; Connection Problem
IT WAS REPORTED THE CONNECTING TUBE CONNECTORS DID NOT HAVE FULL CONNECTION DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218232 ↗MalfunctionNov 21, 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 20747194 ↗MalfunctionNov 21, 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 20747137 ↗MalfunctionOct 25, 2024Break; Break
IT WAS REPORTED THAT CONNECTING TUBE EXHIBITED BROKEN CONNECTORS. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20535899 ↗MalfunctionOct 23, 2024Break; Break
IT WAS REPORTED THAT DURING REPROCESSING FOUND THE CONNECTING TUBE HAD BROKEN CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20519338 ↗MalfunctionOct 23, 2024Break; Break
IT WAS REPORTED THAT DURING REPROCESSING FOUND THE CONNECTING TUBE HAD BROKEN CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20519331 ↗MalfunctionOct 23, 2024Break; Break
IT WAS REPORTED THAT DURING REPROCESSING FOUND THE CONNECTING TUBE HAD BROKEN CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20518791 ↗MalfunctionOct 23, 2024Connection Problem; Connection Problem
IT WAS REPORTED, THAT THE CONNECTING TUBE WAS BROKEN. THE ISSUE WAS FOUND, DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20518126 ↗MalfunctionOct 23, 2024Connection Problem; Connection Problem
IT WAS REPORTED, THAT THE CONNECTING TUBE WAS BROKEN. THE ISSUE WAS FOUND, DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517996 ↗
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-2111Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall164 reports
- CONNECTING TUBE MAJ-2113Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall159 reports
- CONNECTING TUBE MAJ-2112Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall143 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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