Karl Storz Endoscopy Recall 95975
Description: KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Karl Storz Endoscopy Recall 95975 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1052-2025 |
| Event ID | 95975 |
| Event Description | KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 221 units |
| Recall Reason | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| Device Classification | 20250205 |
| Device Code Info | All Lots/UDI: 04048551232095 |
| Center Classification Date | 20250130 |
| Recall Initiation Date | 20241219 |
| Recalling Firm | Karl Storz Endoscopy |
| Initial Notification | Letter |
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