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Open, Classified

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

FDA Recall Z-3300-2026 · Posted 2026-09-25

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeHIH
Date Initiated2026-08-24
Product Quantity50 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.

K890328ADULT RESECTOSCOPECircon Video · 1990-02-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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