Olympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
Olympus Corporation of the Americas is recalling 72 units of the M3 Gold Autoclavable Foroblique Telescope 30 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, but the source text describes a labeling discrepancy regarding sterilization parameters without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving labeling errors or low-risk issues where harm has not been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 72 units of the Olympus M3 Gold Autoclavable Foroblique Telescope 30, Model Number M3-30A. 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 affected units were distributed internationally to Japan. The recall includes all serial numbers for the product, identified by UDI-DI 00821925005679. No specific dates or additional distribution details are provided in the source text.
Consumers and healthcare facilities should stop using the affected devices and contact Olympus Corporation of the Americas for further instructions regarding the recall.
The recalled product
- Product
- Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 72
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: M3-30A. UDI-DI: 00821925005679. All Serial Numbers.
Distribution
Distribution scope not specified by the agency.
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