Z-1051-2025 Class II Ongoing

Recalled by Karl Storz Endoscopy — El Segundo, CA

Recall Details

Product Type
Devices
Report Date
February 5, 2025
Initiation Date
December 19, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 Units

Product Description

KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123

Reason for Recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Distribution Pattern

US Nationwide distribution.

Code Information

All Lots/UDI: 04048551231296