SINGLE USE DISTAL COVERRecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one SINGLE USE DISTAL COVER model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 818
- Deaths reported
- 0
- Injuries reported
- 339
- Recalls
- 3
We found 3 models of SINGLE USE DISTAL COVER by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 818 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2020 and Sep 29, 2026 — classified as 339 injuries, 479 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (592 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
SINGLE USE DISTAL COVER recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 5, 2026Open, Classified
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Z-2676-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Dec 8, 2023Open, Classified
Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.
Z-1071-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Apr 18, 2023Open, Classified
The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.
Z-1613-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported SINGLE USE DISTAL COVER problems
Device problems
- Detachment of Device or Device Component592
- Break65
- Use of Device Problem55
- Separation Problem40
- Device Fell37
- Material Separation34
- Crack30
- Adverse Event Without Identified Device or Use Problem27
Patient problems
- No Clinical Signs, Symptoms or Conditions548
- Foreign Body In Patient90
- Unspecified Tissue Injury80
- Laceration(s)39
- Hemorrhage/Blood Loss/Bleeding26
- No Consequences Or Impact To Patient15
- Insufficient Information10
- Laceration(s) of Esophagus9
SINGLE USE DISTAL COVER models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SINGLE USE DISTAL COVER MAJ-2315Endoscope, accessories, narrow band spectrum1 recall520 reports
- SINGLE USE DISTAL COVER MAJ-2315Accessories, Cleaning, For Endoscope2 recalls294 reports
- SINGLE USE DISTAL COVER MAJ-2315Duodenoscope And Accessories, Flexible/Rigid4 reports
Recent SINGLE USE DISTAL COVER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932389 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
The customer reported the distal cover fell off the end of the scope. This event occurred during reprocessing after an Endoscopic Retrograde Cholangiopancreatography procedure involving an Olympus Distal Cover. There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918148 ↗InjurySep 23, 2026Material Rupture
It was reported that after the Endoscopic Retrograde Cholangiopancreatography was completed, while the duodenoscope was being withdrawn, the single-use disposable protective cover on the distal tip ruptured, causing an esophageal injury with bleeding. As a result of this complication, endoscopic intervention was required, involving the application of clips to close the injury and control the bleeding. It was noted that the same incident occurred in two patients on separate days using the same lot number. The patients required one additional day of hospitalization. This report is 2 of 2 patients involved.
Patient problems: Laceration(s) of Esophagus
MAUDE report 50872696 ↗InjurySep 23, 2026Material Rupture
It was reported that after the Endoscopic Retrograde Cholangiopancreatography was completed, while the duodenoscope was being withdrawn, the single-use disposable protective cover on the distal tip ruptured, causing an esophageal injury with bleeding. As a result of this complication, endoscopic intervention was required, involving the application of clips to close the injury and control the bleeding. It was noted that the same incident occurred in two patients on separate days using the same lot number. The patients required one additional day of hospitalization. This report is 1 of 2 patients involved.
Patient problems: Laceration(s) of Esophagus
MAUDE report 50872667 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302196 ↗MalfunctionAug 13, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233734 ↗MalfunctionJul 28, 2026Device Fell
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057143 ↗MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DISTAL END COVER FELL OFF THE SCOPE DURING TESTING PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215103 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DISTAL COVER WAS NOT ATTACHED TO THE SCOPE. THE EVENT OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) DIAGNOSTIC PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION AND DEVICE WAS INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082940 ↗InjuryMay 4, 2026Detachment of Device or Device Component
DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PORTION OF THE CAP THAT SECURES IT TO THE SCOPE SNAPPED, RESULTING IN THE CAP DETACHING AND LODGING IN THE PATIENT'S VOCAL CORD REGION. THE PATIENT WAS SUBSEQUENTLY INTUBATED, AND THE DETACHED CAP WAS SUCCESSFULLY RETRIEVED USING A THIRD-PARTY FORCEPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25065402 ↗MalfunctionMay 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DISTAL COVER HAD DETACHED FROM THE DUODENOVIDEOSCOPE AND FELL INTO THE DUODENUM. THE ISSUE WAS IDENTIFIED DURING SEDATION WHILE THE DEVICE WAS INSIDE OF THE PATIENT AND RESULTED IN A PROCEDURAL DELAY. THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY DIAGNOSTIC PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SIMILAR OLYMPUS DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058385 ↗MalfunctionMay 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DISTAL COVER HAD A DETACHED DISTAL CAP. THE ISSUE WAS FOUND DURING SEDATION FOR AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE, THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057608 ↗MalfunctionApr 23, 2026Detachment of Device or Device Component
IT WAS REPORTED THE SINGLE USE DISTAL COVER EXHIBITED DEVICE WAS NOT ABLE TO FULLY SEAT AND KEPT FALLING OFF THE DISTAL END OF THE SCOPE. THE EVENT OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM) THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965995 ↗MalfunctionApr 21, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24936466 ↗MalfunctionApr 21, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT IN THE DISTAL COVER, THE DISTAL CAP CAME OFF DURING A PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24936455 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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