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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus M3 Gold Autoclavable Lateral Telescope 70

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 Class 2 Device Recall Olympus M3 Gold Autoclavable Lateral Telescope 70see related information
Date Initiated by FirmAugust 24, 2026
Date PostedSeptember 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3300-2026
Recall Event ID 99779
510(K)NumberK890328 
Product Classification Hysteroscope (and accessories) - Product Code HIH
ProductOlympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Code Information Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactAshley Troiani
484-5531029
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOlympus 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.
Quantity in Commerce50 units
DistributionInternational distribution to the country of Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HIH
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