Recall Z-1061-2025 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123
| Date | Jan 30, 2025 (initiated Dec 19, 2024) |
| Status | Open, Classified |
| Reason | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| Root cause | Labeling Change Control |
| Action | On December 19, 2024, Karl Storz, issued an "Urgent: Medical Device Correction" notification to affected consignees via UPS. In addition to informing consignees about the recall, Karl Storz asked consignees to take the following actions: 1. Immediately discard any previous revisions of the IFU. 2. Access the updated e-IFU at the following link: https://www.karlstorz.com/de/en/eifu.htm?q=&country=US 3. Pass on this Urgent Medical Device Correction to all users of the recalled products and all other persons who need to be aware within your organization. 4. If you have or may have distribute |
| Quantity | 82 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233372 | KARL STORZ Fiber Telescopes for Urology Karl Storz SE & CO. KG, Jul 25, 2024 |