KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
FDA Recall #Z-1054-2025 — Class II — December 19, 2024
Product Description
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, 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
39 units
Distribution
US Nationwide distribution.
Code Information
All Lots/UDI: 04048551231234
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated