Gyrus ACMI BE-558Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925038189), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 28, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED CUSTOMER WAS REUSING THE DISPOSABLE ITEM AND HAD ASKED THE FACILITY CUSTOMER REPRESENTATIVE (REP.) FOR REPROCESSING INFORMATION AND IF IT HAD ANY REUSABLE ELECTRODES. THERE IS NO PATIENT INFECTION ASSOCIATED ON THIS REPORTED EVENT. NO PATIENT HARM OR INJURY REPORTED, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127124 ↗

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-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-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-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