Z-3299-2026

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

Name: Z-3299-2026 Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A
Creator: Olympus Corporation of the Americas
Published: 2026-08-24
License: https://open.fda.gov/license/

Olympus Corporation of the Americas / initiated 2026-08-24 / Open, Classified

FDA source

Recall record

Recall number: Z-3299-2026
Status: Open, Classified
Initiated: 2026-08-24
Posted: 2026-09-25
Recalling firm: Olympus Corporation of the Americas
Product: Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Product code: HIH Hysteroscope (And Accessories)
Reason for recall: 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: Process control
Action: 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.
Quantity in commerce: 72 units
Distribution: International distribution to the country of Japan.
Product codes and lots: Model Number: M3-30A. UDI-DI: 00821925005679. All Serial Numbers.

Product code HIH

K890328Class IIAdult ResectoscopeCircon Video / cleared 1990-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-29. View this recall on fda.gov (opens on fda.gov)