Karl Storz recalls pediatric ureterorenoscope models with unapproved reprocessing methods that may not meet FDA safety standards. Affected units include specific serial numbers and lots.
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 pediatric ureterorenoscopes that have reprocessing instructions not approved by the FDA. This could pose safety risks if used improperly.
The reprocessing instructions for these scopes have not been reviewed by the FDA for safety and efficacy. This means the procedures could be unsafe if the scopes are cleaned or reused without proper approval.
Healthcare professionals using the specific model for pediatric urological procedures are most at risk. Patients receiving these procedures may also be affected.
Check for the model number 27002KP on the product. Affected units have specific serial numbers starting with 04048551231234.
Look for the model number 27002KP and serial numbers starting with 04048551231234.
The recall states that the reprocessing instructions have not been approved by the FDA for safety and efficacy, so it may not be safe to use as intended.
The recall record does not specify a remedy, so contact Karl Storz directly for guidance.
Check for the model number 27002KP and serial numbers starting with 04048551231234.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1054-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1054-2025 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.
