Karl Storz Endoscopy recalls two laser surgical instruments due to lack of validated reprocessing methods, increasing infection risk after reuse. Affected models include REF 8694 and 461000.
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.
Karl Storz Endoscopy is recalling two laser surgical instruments because they lack a proven way to safely reprocess them after use. This increases the risk of infection if the instruments are reused without proper sterilization.
These laser instruments do not have a validated reprocessing method, meaning they cannot be safely cleaned and sterilized after use. If reused without proper sterilization, they can expose patients to infections.
Healthcare professionals using these instruments in surgeries or procedures. Patients undergoing procedures with these instruments are at risk of infection if the instruments are reused without proper sterilization.
Check for the model reference numbers 8694 or 461000 on the instruments. These were sold with specific serial numbers: 8694/04048551216392 and 461000/04048551164860.
Look for the model reference numbers 8694 or 461000 on the instruments.
The instruments lack a validated reprocessing method, increasing the risk of infection if reused without proper sterilization.
Check for the model reference numbers 8694 or 461000 on the instruments, with specific serial numbers 8694/04048551216392 and 461000/04048551164860.
The recall does not specify a remedy, so contact Karl Storz Endoscopy directly for guidance.
We’ve drafted a message you can send Karl Storz Endoscopy to request your refund or repair — edit it as you like.
Subject: Recall Z-1809-2024 — Karl Storz Endoscopy Karl Storz Endoscopy Hello, I own a Karl Storz Endoscopy that is covered by recall Z-1809-2024 from Karl Storz Endoscopy. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
