Karl Storz recalls ureteroscopes with model 27001K due to unapproved reprocessing methods. This could pose safety risks if used without FDA-reviewed procedures. Affected units include specific lots and 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 ureteroscopes with model number 27001K because their instruction manuals include reprocessing methods not approved by the FDA for safety and effectiveness. This could lead to safety issues if the device is cleaned or reused without proper FDA-reviewed steps.
The device's instruction manual includes reprocessing methods that have not been reviewed and approved by the FDA. This means the cleaning and reuse process might not be safe or effective, potentially causing harm to users.
Healthcare professionals using ureteroscopes for medical procedures are most at risk. Patients receiving these procedures may also be affected if the device is not handled correctly.
Check for the model number 27001K on the ureteroscope. Affected units have specific lot numbers and serial numbers starting with 04048551231227.
Look for the model number 27001K and lot numbers starting with 04048551231227 on the device.
The recall is for healthcare professionals using the device. Patients are affected only if the device is used without proper reprocessing steps.
Check for the model number 27001K and lot numbers starting with 04048551231227 on the device.
The recall does not specify a remedy, so contact Karl Storz Endoscopy directly for guidance.
We’ve drafted a message you can send Karl Storz Endoscopy to request your refund or repair — edit it as you like.
Subject: Recall Z-1062-2025 — Karl Storz Endoscopy Karl Storz Endoscopy Hello, I own a Karl Storz Endoscopy that is covered by recall Z-1062-2025 from Karl Storz Endoscopy. 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.
