Z-3299-2026 Class II Ongoing
FDA device recall Z-3299-2026 was initiated by Olympus Corporation Of The Americas on Aug 24, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 72 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2026
- Initiation Date
- Aug 24, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 units
Product Description
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
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.
Distribution Pattern
International distribution to the country of Japan.
Code Information
Model Number: M3-30A. UDI-DI: 00821925005679. All Serial Numbers.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3299-2026
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026