- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
- Affected products (lot / model / serial)
- Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
- Units affected
- 335 units
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
- Firm location
- Center Valley, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3035-2026
- Recall initiated
- August 18, 2026
- FDA classification date
- August 26, 2026
- FDA report date
- September 2, 2026
- FDA event ID
- 99607
- Last updated on HTM Vibe
- September 8, 2026