Karl Storz recalls ureteroscopes with unapproved reprocessing methods that may not meet FDA safety standards. Affected models include 27011K (8 Fr., 6.5mm, 34cm) sold globally. Consumers should contact Karl Storz for details.
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 unapproved reprocessing methods that haven't been reviewed by the FDA for safety. This could mean the devices aren't safe for medical use, putting patients at risk during procedures.
The ureteroscopes have reprocessing instructions that haven't been approved by the FDA. This means the cleaning and sterilization methods might not be safe, potentially causing infections or device failure during medical procedures.
Medical professionals using the recalled ureteroscopes for procedures are most at risk. Patients undergoing surgeries with these devices could face safety issues.
Check for the model number 27011K on the device. The product was sold globally with specific serial numbers starting with 04048551231357.
Reach out to Karl Storz directly for specific instructions on how to handle the recalled ureteroscope.
The reprocessing instructions for these ureteroscopes have not been reviewed and approved by the FDA for safety and efficacy.
The official recall notice does not specify a remedy, so contact Karl Storz directly for guidance.
The recall indicates that the reprocessing methods have not been approved by the FDA, so the device may not be safe for medical procedures.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1064-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1064-2025 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.
