Olympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
Olympus is recalling 50 units of the M3 Gold Autoclavable Lateral Telescope 70 in Japan due to discrepancies between sterilization parameters in the Instructions for Use and the Japanese package insert.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling discrepancy regarding sterilization parameters. The source text explicitly states no illnesses or injuries have been reported, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Olympus Corporation of the Americas is recalling 50 units of the Olympus M3 Gold Autoclavable Lateral Telescope 70, Model Number M3-70A. The recall affects all serial numbers associated with UDI-DI 00821925005686. The product was distributed internationally to the country of Japan.
The recall was initiated because of identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and users in Japan should stop using the affected telescopes and contact Olympus Corporation of the Americas for further instructions regarding the recall.
The recalled product
- Product
- Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.
Distribution
Distribution scope not specified by the agency.
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