Karl Storz recalls ureteroscopes with model 27002K due to unapproved reprocessing methods that may not meet FDA safety standards. 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 27002K because their instruction manuals include reprocessing methods not approved by the FDA. This could lead to safety risks if used improperly.
The reprocessing methods described in the device's instructions have not been reviewed by the FDA for safety and effectiveness. This means the procedures could potentially cause harm if the device is reprocessed incorrectly.
Healthcare professionals using ureteroscopes for medical procedures are likely affected. Those with the specific model and lot numbers from the recall list are at risk.
Check for the model number 27002K on the ureteroscope. Affected units have specific lot numbers starting with 04048551231227.
Identify the model number and lot numbers on your ureteroscope to confirm if it is affected.
The recall is due to reprocessing methods in the device's instructions that have not been approved by the FDA for safety and effectiveness.
Check for the model number 27002K and lot numbers starting with 04048551231227 on the device.
The recall record does not specify a remedy, so contact Karl Storz Endoscopy 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-1063-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1063-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
