KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Reported: February 5, 2025 Initiated: December 19, 2024 #Z-1051-2025
Product Description
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Reason for Recall
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Details
- Recalling Firm
- Karl Storz Endoscopy
- Units Affected
- 4 Units
- Distribution
- US Nationwide distribution.
- Location
- El Segundo, CA
Frequently Asked Questions
What product was recalled? ▼
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123. Recalled by Karl Storz Endoscopy. Units affected: 4 Units.
Why was this product recalled? ▼
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2025. Severity: Moderate. Recall number: Z-1051-2025.
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