Elite 2 System E2OS-CF25Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00821925003408), received between Aug 4, 2022 and Sep 20, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

7 other recalls cover devices cleared under the same FDA submission (K890328); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE PLASTIC TIP WAS BROKEN. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456493 ↗
• MalfunctionSep 12, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE PLASTIC TIP WAS BROKEN. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403189 ↗
• MalfunctionSep 12, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE PLASTIC TIP WAS BROKEN. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402248 ↗
• MalfunctionSep 9, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE PLASTIC TIP WAS CRACKED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395976 ↗
• MalfunctionSep 9, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE PLASTIC TIP HAD CRACKED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395643 ↗
• MalfunctionSep 8, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TIP IS BROKEN. THE REPORTED PROBLEM WAS FOUND DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15383601 ↗
• MalfunctionAug 4, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE PLASTIC TIP WAS BROKEN ON THE OUTER SHEATH. THE REPORTED PROBLEM WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164047 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K890328. One submission often covers many models, so check the product and lot details in each record.

• Z-3300-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
• Z-3299-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
• Z-2720-2026 · May 5, 2026 · Open, Classified
  Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
• Z-2140-2025 · Jun 18, 2025 · Open, Classified
  Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the work
• Z-2139-2025 · Jun 18, 2025 · Open, Classified
  Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some
• Z-0568-2024 · Oct 2, 2023 · Open, Classified
  ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF M
• Z-1952-2018 · Apr 17, 2018 · Terminated
  Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs t