Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods. FDA requires safety review before use. Affected units include specific lot numbers.
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Karl Storz is recalling uretero-renoscope devices that have reprocessing instructions not approved by the FDA. This could pose safety risks if used without proper FDA-reviewed procedures.
The reprocessing instructions for these scopes have not been reviewed by the FDA for safety and effectiveness. Using them without approved procedures could lead to medical complications.
Healthcare professionals using these devices for medical procedures are most at risk. The recall affects specific models sold with unapproved reprocessing instructions.
Check for the model reference 27001L, uretero-renoscope, 8 Fr., 6½, 43 cm, non-sterile, RxOnly, CE 0123. Affected units have specific lot numbers starting with 04048551231210.
Identify the model reference 27001L, uretero-renoscope, 8 Fr., 6½, 43 cm, non-sterile, RxOnly, CE 0123.
The reprocessing instructions for these scopes have not been reviewed and approved by the FDA for safety and efficacy.
The recall record does not specify a remedy or action steps for affected devices.
Yes, affected units have specific lot numbers starting with 04048551231210.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1057-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1057-2025 from Karl Storz. 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.
