Drug recall
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA recall event 95975 · Class II · Karl Storz Endoscopy
Key facts
| Event ID | 95975 |
|---|---|
| Recall numbers | Z-1051-2025, Z-1052-2025, Z-1053-2025, Z-1054-2025, Z-1055-2025, Z-1056-2025, Z-1057-2025, Z-1058-2025, Z-1059-2025, Z-1060-2025, Z-1061-2025, Z-1062-2025 and 2 more |
| Recalling firm | Karl Storz Endoscopy |
| Product type | Devices |
| Products | KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123, KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123, KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123, KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123, KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123 and 9 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| Initiation date | Dec 19, 2024 |
| Report date | Feb 5, 2025 |
| City | El Segundo |
| State | CA |
| Country | United States |
| FEI number | 3007475226 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: