Karl Storz recalls ureteroscopes with model 27010K (7Fr, 34cm) due to unapproved reprocessing methods. This could pose safety risks during medical use. Affected units include specific lots with UDI 04048551231319.
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 27010K (7Fr, 34cm) because their instruction manuals include reprocessing methods not approved by the FDA. This could lead to safety issues during medical procedures if improperly handled.
The device's instruction manuals include reprocessing methods that have not been reviewed and approved by the FDA for safety and effectiveness. This means improper reprocessing could lead to safety issues during medical procedures.
Medical professionals using the ureteroscope for procedures are likely affected. Patients undergoing procedures with this device may be at risk if the reprocessing is done incorrectly.
Check for the model number 27010K (7Fr, 34cm) on the ureteroscope. Affected units have a unique device identifier (UDI) starting with 04048551231319.
Identify the model number and UDI to confirm if your ureteroscope is affected.
The recall indicates the reprocessing methods in the instructions have not been approved by the FDA, so it may pose safety risks during medical procedures.
Check for the model number 27010K (7Fr, 34cm) and a unique device identifier (UDI) starting with 04048551231319.
The recall 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-1060-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1060-2025 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.
