Karl Storz recalls endoscopy devices with unapproved reprocessing methods that may not meet FDA safety standards. Affected products include specific models sold under CE 0123 certification.
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 certain endoscopy devices because their instructions for reprocessing haven't been approved by the FDA for safety and efficacy. This could pose risks during medical procedures if used improperly.
The devices' instructions for reprocessing have not been reviewed by the FDA for safety and efficacy. This means the reprocessing methods could lead to unsafe conditions during medical procedures if not properly followed.
Medical professionals using Karl Storz endoscopy devices with the specified model and lot numbers are most at risk. Patients receiving procedures with these devices may also be affected.
Check for the model name 'Hopkins Telescope 6' with reference number 27293AA and CE 0123 certification. The affected products have specific lot numbers starting with (01)04048551233795.
Identify the model name and reference number on the device to confirm if it matches the recalled items.
The recall states that the reprocessing instructions have not been approved by the FDA for safety and efficacy, so they may not be safe for use as intended.
The recall record does not specify a remedy, so the official notice does not provide instructions on what to do with the device.
Check for the model name 'Hopkins Telescope 6', reference number 27293AA, and CE 0123 certification with the specific lot numbers starting with (01)04048551233795.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-3221-2024 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-3221-2024 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.
