M3 Gold recallZ-3300-2026 · Olympus Corporation of the Americas · initiated Aug 24, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
FDA root cause category: Process control
What the company is doing
Olympus notified the single Japanese distributor on about 08/24/2026 via emailed "URGENT: FIELD SAFETY NOTICE." Consignees and end users are being instructed to store a copy of the provided correct sterilization parameters with current package insert, use only the corrected sterilization parameters, complete and return the provided reply form, and if units have been further distributed, notify those customers.
Recall details
- Recall number
- Z-3300-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 24, 2026
- Posted by the FDA
- Sep 25, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 50 units
- Product code
- HIH
- FDA submissions
- K890328
- Distribution
- International distribution to the country of Japan.
Product description
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Code information (models, lots, serial numbers)
Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- M3 Gold M3-70AGyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall0 reports
Product lines
Other devices under the same FDA submission
39 devices cleared under K890328 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- M3 Gold M3-30AGyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall11 reports
- USA Elite MLE-24-012Gyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall9 reports
- Classic Series C650-129AGyrus ACMI, LLC · Hysteroscope (And Accessories)1 recall4 reports
- Blue Silicone CS-B612Gyrus ACMI, LLC · Hysteroscope (And Accessories)1 recall2 reports
- USA Elite RBGyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall1 report
- Gyrus ACMI 194Gyrus ACMI, LLC · Hysteroscope (And Accessories)1 recall0 reports
- USA Elite 190-NRSGyrus ACMI, LLC · Hysteroscope (And Accessories)1 recall0 reports
- Gyrus ACMI CS-G7Gyrus ACMI, LLC · Hysteroscope (And Accessories)1 recall0 reports
- USA Elite EIS-HCF25Gyrus ACMI, LLC · Hysteroscope (And Accessories)25 reports
- M3 Gold REXM3-30AGyrus ACMI, LLC · Hysteroscope (And Accessories)14 reports
- USA Elite EMRS-26BGyrus ACMI, LLC · Hysteroscope (And Accessories)9 reports
- Elite 2 System E2OS-CF25Gyrus ACMI, LLC · Hysteroscope (And Accessories)7 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99779).
- Z-3299-2026 · Open, ClassifiedOlympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page