KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Reported: February 5, 2025 Initiated: December 19, 2024 #Z-1053-2025
Product Description
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
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
- 185 units
- Distribution
- US Nationwide distribution.
- Location
- El Segundo, CA
Frequently Asked Questions
What product was recalled? ▼
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE. Recalled by Karl Storz Endoscopy. Units affected: 185 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-1053-2025.
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