FDA Enforcement
Class II
Ongoing
KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
Recall: Z-1064-2025
·
Reported February 5, 2025
Enforcement
- Recall Number
- Z-1064-2025
- Event ID
- 95975
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Karl Storz Endoscopy
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 5, 2025
- Initiation Date
- December 19, 2024
- Classification Date
- January 30, 2025
- Address
- 2151 E Grand Ave, El Segundo, CA, 90245-5017, United States
Description
KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
Reason
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Code Info
All Lots/UDI:04048551231357
Distribution
US Nationwide distribution.
Quantity
299 units