CLEANASCOPE Sterile Tray Liner SystemRecalls & reported problems
Cantel Medical (Italy) Srl · The CLEANASCOPE Sterile Liner System consists of sterile red and green covers and a sterile clear base liner to be used as part of the CLEANASCOPE system that provides identification of Clean and Contaminated equipment. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 18011517135801), received between Nov 11, 2022 and Jun 16, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
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.
MalfunctionJun 16, 2026Insufficient Device Problem Information
THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT THE STERILE TRANSPARENT ENDOSCOPE COVER TO THEIR CLEANASCOPE "TEARS AS SOON AS TENSION IS APPLIED TO IT ON THE TRAY". NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524330 ↗MalfunctionNov 11, 2022No Apparent Adverse Event; No Apparent Adverse Event
THE USER FACILITY REPORTED THAT THE WHITE LINER TEARS, ALONG THE CENTRAL FOLD, WHEN IT IS UNFOLDED PRIOR TO BEING INSTALLED IN THE BOTTOM OF THE TRAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15780843 ↗
Other Adaptor, bulbs, miscellaneous, for endoscope devices
- NA M0067201010Boston Scientific Corporation · Adaptor, bulbs, miscellaneous, for endoscope14 reports
- NA M0067201000Boston Scientific Corporation · Adaptor, bulbs, miscellaneous, for endoscope6 reports
- LithoVue Empower™ M0067919900Boston Scientific Corporation · Adaptor, Bulbs, Miscellaneous, For Endoscope1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page