Class II
Medical Device Recall: KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, 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
299 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1064-2025
Status: ongoing
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