FDAFDA · Food and drugs·Recall number Z-1051-2025
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Published February 5, 2025 · Recall initiated: December 19, 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
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Karl Storz Endoscopy
- Distributor
- US Nationwide distribution.
- Lot
- All Lots/UDI: 04048551231296
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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