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FEBClass 2

Accessories, Cleaning, For Endoscope

FDA adverse event reports and recall history for accessories, cleaning, for endoscope (product code FEB), from the public MAUDE corpus and the live FDA recall database.

Total reports
5,104
Deaths
22
Injuries
410
Malfunctions
4,457

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

  • 2026-10-14Open, ClassifiedProcess change control

    RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115

    If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.

  • 2026-10-14Open, ClassifiedProcess change control

    RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116

    If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.

  • 2026-10-14Open, ClassifiedProcess change control

    RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117

    If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.

  • 2026-04-22Open, ClassifiedDevice Design

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

    Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

  • 2026-04-22Open, ClassifiedDevice Design

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111

    Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

  • 2026-04-22Open, ClassifiedDevice Design

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

    Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

  • 2026-04-22Open, ClassifiedDevice Design

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

    Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

  • 2026-04-22Open, ClassifiedDevice Design

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.

    Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

  • 2026-04-22Open, ClassifiedDevice Design

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.

    XXX

  • 2026-04-22Open, ClassifiedDevice Design

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

    Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

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