Z-1063-2025 Class II Ongoing
FDA device recall Z-1063-2025 was initiated by Karl Storz Endoscopy on December 19, 2024 and is designated Class II. Reason for recall: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. The recall status is ongoing. Affected quantity: 180 units.
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
- 180 units
Product Description
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 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.
Distribution Pattern
US Nationwide distribution.
Code Information
All Lots/UDI:04048551231227