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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1809-2024%22
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