Karl Storz recalls ureterorenoscopes with unapproved reprocessing methods that may pose safety risks. Affected models include 27003L (9.5 Fr., 43cm) sold with CE0123 marking. 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 ureterorenoscopes that have unapproved reprocessing instructions. This could lead to safety issues if the device isn't properly cleaned and reused. Affected models include the 27003L (9.5 Fr., 43cm) with CE0123 marking.
The reprocessing instructions for these scopes have not been reviewed by the FDA for safety and efficacy. This means improper cleaning could lead to infections or device failure during use.
Medical professionals using ureterorenoscopes for procedures may be affected. Patients using these devices for specific treatments could also be impacted.
Check for the model number 27003L, 9.5 Fr., 43cm, and CE0123 marking on the device. The product was sold with a specific lot number starting with 04048551231296.
Reach out to Karl Storz directly for specific instructions on how to handle the recalled device.
The recall states that the reprocessing instructions have not been approved by the FDA for safety and efficacy, which could pose risks if the device isn't properly cleaned.
Check for the model number 27003L, 9.5 Fr., 43cm, and CE0123 marking on the device. The product was sold with a specific lot number starting with 04048551231296.
Contact Karl Storz directly for specific instructions on how to handle the recalled device.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1051-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1051-2025 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.
