FDAFDA · Food and drugs·Recall number Z-0697-2024
Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
Published January 17, 2024 · Recall initiated: November 6, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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