Karl Storz Endoscopy recalls flexible 1mm grasping forceps (UDI: 04048551050255) due to inadequate reprocessing validation evidence. Affected units include all lots sold.
Inadequate reprocessing validation evidence
Karl Storz Endoscopy is recalling flexible 1mm grasping forceps (UDI: 04048551050255) because reprocessing validation evidence is inadequate. This could lead to improper sterilization and potential infection risks for medical users.
The forceps may not be properly sterilized due to insufficient reprocessing validation evidence. This could lead to cross-contamination and infection risks during medical procedures if the devices are reused without adequate validation.
Healthcare professionals and medical facilities using the recalled forceps. Those most at risk are users who rely on the forceps for procedures without proper sterilization validation.
Check for the UDI code 04048551050255 on the product. All lots of the flexible 1mm grasping forceps (Rx Only) from Karl Storz Endoscopy are affected.
Look for the UDI code 04048551050255 on the forceps to confirm if it's affected.
The recall is due to inadequate reprocessing validation evidence, which could lead to improper sterilization and infection risks.
Check for the UDI code 04048551050255 on the flexible 1mm grasping forceps (Rx Only). All lots are affected.
The official recall notice does not specify a remedy or action steps beyond checking the UDI code.
We’ve drafted a message you can send Karl Storz Endoscopy to request your refund or repair — edit it as you like.
Subject: Recall Z-1472-2024 — Karl Storz Endoscopy Karl Storz Endoscopy Hello, I own a Karl Storz Endoscopy that is covered by recall Z-1472-2024 from Karl Storz Endoscopy. 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.