Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods that may pose safety risks. Affected units include specific lot numbers and CE 0123 marked devices.
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 lead to safety issues if the devices are reprocessed incorrectly.
The reprocessing instructions for these devices have not been reviewed by the FDA for safety and efficacy. This means improper reprocessing could cause harm during medical procedures.
Healthcare professionals using these devices for medical procedures are most at risk. Patients receiving procedures with these devices may also be affected.
Check for the model number 27010L, uretero-renoscope, 7 Fr., 43cm, non-sterile, RxOnly, and CE 0123 marking. Affected units have specific lot numbers starting with 04048551231333.
Identify the model number, size, and CE marking to confirm if your device is affected.
The reprocessing instructions for these devices have not been reviewed and approved by the FDA for safety and efficacy.
The recall record does not specify a remedy, so check with Karl Storz for guidance.
Yes, affected units have lot numbers starting with 04048551231333.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1055-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1055-2025 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.
