Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods. This device requires FDA-reviewed reprocessing to prevent safety risks. Affected units have specific serial 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 use reprocessing methods not approved by the FDA. This could lead to safety issues if the device is reprocessed incorrectly.
The device's instructions for reprocessing have not been reviewed by the FDA for safety and effectiveness. This means improper reprocessing could cause harm during medical procedures.
Healthcare professionals using the uretero-renoscope for medical procedures are most at risk. Patients receiving procedures with this device may also be affected.
Check for the model number 27002L, uretero-renoscope, 9.5 Fr., 6 inches, 43 cm, non-sterile, Rx-only, CE 0123. Affected units have specific serial numbers starting with 04048551231265.
Look for the model number 27002L, uretero-renoscope, 9.5 Fr., 6 inches, 43 cm, non-sterile, Rx-only, CE 0123.
The device's reprocessing instructions have not been reviewed and approved by the FDA for safety and effectiveness.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected model.
Check for the model number 27002L, uretero-renoscope, 9.5 Fr., 6 inches, 43 cm, non-sterile, Rx-only, CE 0123 with serial numbers starting with 04048551231265.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1059-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1059-2025 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.
