Karl Storz recalls specific endoscopy devices due to unapproved reprocessing methods that may not meet FDA safety standards. Affected devices include Hopkins Telescope 6 models with certain 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 specific 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 without proper oversight.
The devices' instructions for reprocessing have not been reviewed by the FDA for safety and effectiveness. This means the reprocessing methods could lead to unsafe conditions during medical procedures if not properly managed.
Medical professionals using Karl Storz endoscopy devices with the specific model and serial numbers listed in the recall are affected. Patients receiving procedures with these devices may also be at risk.
Check for the model 'Hopkins Telescope 6' with the serial number starting with (01)04048551233856. These devices were sold with the CE 0123 certification and are prescription-only.
Look for the serial number starting with (01)04048551233856 on the device packaging or label.
The recall is because the instructions for reprocessing these medical devices have not been approved by the FDA for safety and efficacy.
The official recall notice does not specify a remedy or action for affected devices.
The recall indicates potential safety risks due to unapproved reprocessing methods, but specific injury risks are not detailed in the notice.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-3223-2024 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-3223-2024 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.
