Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
FDA Recall Z-3299-2026 · Posted 2026-09-25
Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeHIH
Date Initiated2026-08-24
Product Quantity72 units
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
International distribution to the country of Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.