Karl Storz recalls nephrosopes with unapproved reprocessing methods that may not be safe for medical use. Affected units have specific serial numbers.
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Karl Storz is recalling nephrosopes (kidney scopes) that use reprocessing methods not approved by the FDA. This could pose safety risks during medical procedures if used improperly.
The device's reprocessing methods have not been reviewed by the FDA for safety and efficacy. This means the device might not work correctly or could cause harm during medical procedures if reprocessed incorrectly.
Medical professionals using the nephroscope for kidney procedures may be affected. Patients receiving these procedures are at risk if the device is used without proper reprocessing.
Check for the model number REF: 27830KA and serial numbers starting with (01)04048551234099. The device is sold under the brand Karl Storz Endoscopy.
Identify the model number and serial number to confirm if your device is affected.
The recall states that reprocessing methods have not been approved by the FDA, so it may not be safe for medical use.
The recall does not specify a remedy, so contact Karl Storz Endoscopy for guidance.
Look for the model number REF: 27830KA and serial numbers starting with (01)04048551234099.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-3224-2024 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-3224-2024 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.
