Karl Storz recalls pediatric cysto-urethroscopes with unapproved reprocessing methods that could pose safety risks. Affected models include REF: 27030KB, all lots/UDI: 04048551:232118.
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 cysto-urethroscopes (model REF: 27030KB) because their instruction manuals include reprocessing methods not approved by the FDA. This could lead to safety issues if used improperly.
The device's instruction manual includes reprocessing steps that have not been reviewed or approved by the FDA for safety and effectiveness. If these methods are used, there is a potential risk of harm during medical procedures.
Parents and healthcare providers who use the recalled pediatric cysto-urethroscopes for medical procedures are most at risk. The product is designed for children, so pediatric patients are particularly affected.
Check for the model number REF: 27030KB on the device. The product was sold with unique identifiers (UDI) starting with 04048551232118.
Look for the model number REF: 27030KB and unique identifiers starting with 04048551232118 on the device.
The recall states that the reprocessing methods in the instruction manual have not been approved by the FDA for safety and efficacy, so it is not safe to use as described.
The recall does not specify a remedy, so the official notice does not provide instructions on what to do with the product.
Check for the model number REF: 27030KB and unique identifiers starting with 04048551232118 on the 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-1053-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1053-2025 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.
