Class II
Medical Device Recall: KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy · December 19, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
185 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1062-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.