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Gyrus ACMI 194Recalls & reported problems

Gyrus ACMI, LLC · Ellik Evacuator Includes Glass Body, Male Connector Tubing, and Latex Bulb · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Jun 18, 2025Open, Classified

    Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

    Z-2143-2025 · Root cause: Packaging change control · FDA record ↗

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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.