Karl Storz recalls nephrosopes with unapproved reprocessing methods that may not be safe for medical use. Affected models include REF: 27840KA, CE 0123.
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 have medical device instructions for reprocessing not approved by the FDA. This could pose safety risks if used improperly.
The medical device instructions include reprocessing methods that haven't been reviewed by the FDA for safety and efficacy. This means the devices might not work correctly or could cause harm if reprocessed improperly.
Healthcare professionals using these nephrosopes for medical procedures may be affected. Patients receiving procedures with these devices could be at risk if reprocessing is done incorrectly.
Check for the model REF: 27840KA with CE 0123 marking. The recall covers all lots and UDI numbers starting with (01)04048551366660.
Identify the model REF: 27840KA and CE 0123 marking to confirm if it's affected.
The recall states that the reprocessing methods in the instructions have not been approved by the FDA for safety and efficacy, so it may not be safe if used incorrectly.
The recall does not specify a remedy, so the official notice does not provide instructions on what to do next.
Look for the model REF: 27840KA with CE 0123 marking and UDI number starting with (01)04048551366660.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-3225-2024 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-3225-2024 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.
