Karl Storz recalls specific sterilization trays due to new 510(k) instructions that may not be fully compatible with sterilization processes. Affected models include 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, and 39317A.
Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
Karl Storz is recalling specific sterilization trays because their new 510(k) instructions may not be compatible with standard sterilization processes. This could lead to improper sterilization of medical devices, posing a risk of infection.
The trays have new 510(k) instructions that specify sterilization modalities. If not properly aligned with the facility's sterilization process, the trays might not sterilize equipment correctly, increasing infection risks.
Healthcare facilities and medical professionals who use these sterilization trays for equipment. Those most at risk are users who follow the new instructions without verifying compatibility with their sterilization system.
Check for model numbers 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, or 39317A on the trays. All lots of these models are affected.
Look for model numbers on the tray to confirm if it is one of the affected models.
Ensure the sterilization process matches the instructions provided with the tray to avoid improper sterilization.
The trays are safe if used with the correct sterilization process as per the instructions. Improper use could lead to infection risks.
Check the model number and ensure your sterilization process matches the instructions to avoid improper sterilization.
All lots of the affected models are included in this recall.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1981-2023 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1981-2023 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.
