Karl Storz recalls five S 5 3x6: sterility not confirmed. Affected units have UDI 04048551446690. Consumers should check if they own these specific sterile endoscopes.
Flexible intubation endoscopes sterility assurance can not be confirmed.
Karl Storz is recalling five S 5 3x65 endoscopes because their sterility cannot be confirmed. This means the devices might not be clean enough for safe medical use, risking infection during procedures.
These endoscopes are designed for single-use sterilization. If the sterility cannot be confirmed, they might not be properly cleaned or disinfected, increasing the risk of infection during medical procedures.
Healthcare professionals who use these endoscopes for medical procedures are most at risk. Patients undergoing procedures with these devices could face infection if the sterility is compromised.
Check for the model 'Five S 5 3x65' with UDI 04048551446690. Units imported into the U.S. with lot numbers 500472 or 500461 are affected.
Look for the model 'Five S 5 3x65' with UDI 04048551446690 or lot numbers 500472/500461.
The sterility of these endoscopes cannot be confirmed, which could lead to infection during medical procedures.
Check for the model 'Five S 5 3x65' with UDI 04048551446690 or lot numbers 500472/500461.
The recall record does not specify a remedy, so contact Karl Storz 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-2589-2023 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-2589-2023 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.
