Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods that could pose safety risks. 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 devices that use reprocessing methods not approved by the FDA. This could create safety risks if the devices are reprocessed incorrectly.
The reprocessing instructions in the device's user manual have not been reviewed or approved by the FDA for safety and effectiveness. This could lead to improper cleaning or sterilization if the device is reprocessed without following approved methods.
Healthcare professionals using the uretero-renoscope for medical procedures are most at risk. The recall affects specific models sold with CE 0123 certification.
Check for the model number 27000L, size 7 Fr., 6½, 43 cm, and non-sterile status. Affected units have specific serial numbers starting with 04048551311271.
Verify the model number, size, and serial number to confirm if your device is affected.
The recall states that the reprocessing instructions have not been approved by the FDA, so it may not be safe if reprocessed incorrectly.
Check for the model number 27000L, size 7 Fr., 6½, 43 cm, and serial numbers starting with 04048551311271.
The recall does not specify a remedy, so contact Karl Storz directly for guidance.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1056-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1056-2025 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.
