Class II
Medical Device Recall: KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
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
4 Units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1051-2025
Status: ongoing
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