Hysteroscope (And Accessories)

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

• 2026-09-25Open, ClassifiedProcess control

  Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.

  There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

• 2026-09-25Open, ClassifiedProcess control

  Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.

  There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

• 2026-07-23Open, ClassifiedPackaging change control

  Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.

  Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

• 2026-02-20Open, ClassifiedUnder Investigation by firm

  Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

• 2025-07-21Open, ClassifiedPackaging change control

  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 contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.

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

• 2025-07-21Open, ClassifiedPackaging change control

  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 working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.

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

• 2024-06-06Open, ClassifiedProcess change control

  OES 4000 Hysteroscope, Model/Catalog Number: A4674A

  The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.

• 2023-11-17Open, ClassifiedUnder Investigation by firm

  Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.

  Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

• 2023-11-17Open, ClassifiedUnder Investigation by firm

  Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

  Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

• 2023-08-29Open, ClassifiedReprocessing Controls

  Visera Hysterovideoscope Olympus HYF Type V

  IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.