USA Elite REXEIS-HCF25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925008205), received between Jul 12, 2020 and Nov 29, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CF RESECTOSCOPE INNER SHEATH, 25FR HAD A BROKEN TIP. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229327 ↗
• MalfunctionJul 12, 2020Break; Break

  THE SERVICE CENTER WAS INFORMED THAT AT THE CONCLUSION OF A THERAPEUTIC PROCEDURE, THE BLACK DISTAL TIP OF THE INNER SHEATH CRACKED INTO TWO PIECES AND FELL INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT¿S BLADDER. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10262329 ↗

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-3299-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
• Z-3300-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
• 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