Karl Storz recalls endoscopy devices with unapproved reprocessing methods. FDA requires safety review before use. Affected devices include specific models and lots.
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 effectiveness. This means the devices could pose risks if used improperly.
The devices' instructions for reprocessing haven't been reviewed by the FDA for safety and effectiveness. This could lead to risks like infections or device failure if the reprocessing isn't done correctly.
Medical professionals who use Karl Storz endoscopy devices with unapproved reprocessing methods are affected. Patients receiving these devices may be at risk if the reprocessing isn't done safely.
Check for the model name 'Hopkins Telescope 6' and the lot number (01)04048551233344 on the device. These devices were sold with a CE 0123 marking and require a prescription.
Look for the model name 'Hopkins Telescope 6' and lot number (01)04048551233344 on the device.
The devices' instructions for reprocessing haven't been reviewed and approved by the FDA for safety and effectiveness.
The recall record doesn't specify a remedy, so there's no action required beyond checking if your device matches the description.
The recall indicates the reprocessing instructions aren't FDA-approved, so the device may pose risks if reprocessed incorrectly.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-3218-2024 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-3218-2024 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.
