Karl Storz recalls endoscopy devices with unapproved reprocessing methods that may not meet FDA safety standards. Affected devices 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 user instructions for reprocessing haven't been approved by the FDA for safety and effectiveness. This could pose risks during medical procedures if the devices are used improperly.
The devices' user instructions for reprocessing have not been reviewed by the FDA for safety and effectiveness. This means the reprocessing methods could lead to improper device function during medical procedures, potentially affecting patient safety.
Medical professionals using Karl Storz endoscopy devices with the specific model and lot numbers listed in the recall notice. Patients receiving procedures with these devices may be at risk if the reprocessing steps are not followed correctly.
Check for the model name 'Hopkins Telescope 6' and the lot number (01)04048551233771 on the device. These devices were sold with CE 0123 certification and require a prescription (Rx only).
Identify the model name 'Hopkins Telescope 6' and lot number (01)04048551233771 on the device.
The user instructions for reprocessing these devices have not been approved by the FDA for safety and effectiveness.
The recall notice does not specify a remedy, so contact Karl Storz Endoscopy directly for guidance.
Yes, the Hopkins Telescope 6 model with lot number (01)04048551233771 is affected.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-3220-2024 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-3220-2024 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.
