Karl Storz recalls ureteroscopes with model 27000K due to unapproved reprocessing methods. This could pose safety risks if used without FDA-reviewed procedures. Affected units sold with CE 0123 marking.
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 ureteroscopes model 27000K because their instruction manuals include reprocessing methods not approved by the FDA. This could lead to safety issues if the devices are cleaned or reused without proper FDA-reviewed steps.
The device's instructions for reprocessing contain methods that haven't been reviewed by the FDA for safety and effectiveness. If these procedures are followed without FDA approval, it could lead to potential safety issues during medical use.
Healthcare professionals using these ureteroscopes for medical procedures are most at risk. Patients receiving procedures with these devices may also be affected if improper reprocessing occurs.
Check for the model number 27000K on the ureteroscope. These devices were sold with CE 0123 marking and have specific lot numbers starting with 04048551310816.
Look for the model number 27000K on the ureteroscope.
Ensure reprocessing follows FDA-approved methods if you use this device.
The recall indicates that the reprocessing instructions have not been approved by the FDA, so using it without approved reprocessing methods could pose safety risks.
Check for the model number 27000K and lot numbers starting with 04048551310816 on the device.
Review the reprocessing instructions to ensure they follow FDA-approved methods. If unsure, contact Karl Storz 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-1061-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1061-2025 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.
