FDA Device recall Z-1473-2024
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE by Karl Storz Endoscopy, citing inadequate reprocessing validation evidence.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1473-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-27 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | US |
Product
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Reason
Inadequate reprocessing validation evidence
Identifiers
| code_info | UDI: 04048551259788/ All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-10-07 · Karl Storz Endoscopy - Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1
FDA Device · Class II · 2026-07-29 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
All Karl Storz Endoscopy recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1473-2024%22
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