FDAFDA · Food and drugs·Recall number Z-0075-2024
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Published October 25, 2023 · Recall initiated: September 22, 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
There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI: 04953170324147; All Serial Numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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