Karl Storz recalls Endoskope Telescope 6 devices with unapproved reprocessing methods. FDA requires safety review before use to prevent risks.
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 Endoskope Telescope 6 medical devices because their instructions for reprocessing haven't been approved by the FDA. This could create safety risks if used without proper review.
The devices' instructions for reprocessing have not been reviewed by the FDA for safety and effectiveness. This means improper reprocessing could lead to medical risks during procedures.
Healthcare providers using these devices for medical procedures are most at risk. Patients receiving procedures with these devices may also be affected.
Check for the model 'Hopkins Telescope 6' with reference number 27093AA. These devices were sold with CE 0123 marking and require a prescription.
Look for the model name 'Hopkins Telescope 6' and reference number 27093AA on the device.
The recall is because the instructions for reprocessing these medical devices haven't been approved by the FDA for safety and effectiveness.
The recall does not specify a stop-use instruction, so you can continue using it if you follow the approved reprocessing methods.
Check for the model 'Hopkins Telescope 6' with reference number 27093AA and CE 0123 marking 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-3219-2024 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-3219-2024 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.
