Karl Storz Endoscopy recalls KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
- Recall date
- December 19, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1057-2025
- FDA classification
- Class II
- Brand / firm
- Karl Storz Endoscopy
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
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