FDA recall Z-1064-2025

Karl Storz Endoscopy · Class II · device

Product

KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, 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

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-12-19
Report date
2025-02-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Segundo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1064-2025