FDA Device recall Z-1809-2024
LASER Application Instrument, 23 cm, REF: 8694
- FDA Device
- Class II
- ongoing
- Published 2024-05-22
On 2024-05-22 the FDA classified a Class II recall of LASER Application Instrument, 23 cm, REF: 8694 by Karl Storz Endoscopy, citing laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1809-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-01 |
| Published | 2024-05-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | US |
Product
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Reason
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
Identifiers
| code_info | All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Karl Storz Endoscopy
- HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visual…
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-1809-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.