Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods. This may pose safety risks if used without FDA-reviewed procedures. Affected units have specific serial numbers and were sold with CE 0123 certification.
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 models that use reprocessing methods not approved by the FDA. This could create safety risks if the device is cleaned or reused without proper FDA-reviewed procedures.
The device's instructions for reprocessing have not been reviewed by the FDA for safety and effectiveness. If healthcare workers use unapproved cleaning methods, it could lead to device failure or infection risks during medical procedures.
Healthcare professionals using this specific uretero-renoscope model for medical procedures are most at risk. Patients receiving procedures with this device may also be affected if improper reprocessing occurs.
Check for the model number 27011L on the device label. Affected units have specific serial numbers starting with 04048551231371. These devices were sold with CE 0123 certification.
Look for the model number 27011L and serial numbers starting with 04048551231371 on the device.
The recall states that the reprocessing methods have not been approved by the FDA for safety and efficacy, so it may not be safe without proper procedures.
The official recall record does not specify a remedy, so contact Karl Storz directly for guidance.
Check for the model number 27011L and serial numbers starting with 04048551231371 on the device label.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1058-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1058-2025 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.
