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USA Elite REXERIS-CF27Recalls & reported problems

Gyrus ACMI, LLC · USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 27.6 Fr (9.2 mm), Color Coded Gray · Class 2

All models of USA Elite (24)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925008298), received between Sep 12, 2022 and Sep 12, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 12, 2022Break; Break

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15406883 ↗

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

Other Hysteroscope (And Accessories) devices

All Hysteroscope (And Accessories) devices →

Sources and updates

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