FDAFDA · Food and drugs·Recall number Z-2331-2024
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Published July 17, 2024 · Recall initiated: June 7, 2024
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
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- Domestic: NY, OH, & DC.
- Lot
- Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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