KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, C...
FDA Recall #Z-1057-2025 — Class II — December 19, 2024
Product Description
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Reason for Recall
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Recalling Firm
Karl Storz Endoscopy — El Segundo, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
59 units
Distribution
US Nationwide distribution.
Code Information
All Lots/UDI: 04048551231210
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated