FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
- Recall number
- Z-3299-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
- Status
- Open, Classified
- Initiated
- 2026-08-24
- Posted
- 2026-09-25
- Terminated
- not on file
- Reason
- There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
- Root cause
- Process control
- 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.
- Quantity
- 72 units
- Distribution
- International distribution to the country of Japan.
- Lot, serial or model codes
- Model Number: M3-30A. UDI-DI: 00821925005679. All Serial Numbers.
- 510(k) numbers
- ["K890328"]
- PMA numbers
- not on file
- Product code
- HIH
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28