Karl Storz recalls specific metal sterilization trays due to new 510(k) instructions for use that may require updated sterilization methods. Affected trays have unique dimensions and reference numbers.
Metal 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 several metal sterilization trays because their new 510(k) instructions for use may not be fully compatible with standard sterilization processes. This could lead to improper sterilization if not followed correctly.
The trays have new 510(k) instructions that specify sterilization methods. If not followed correctly, they could be improperly sterilized, potentially leading to contamination of medical devices.
Medical professionals using Karl Storz endoscopy equipment who own the recalled trays. The risk is low as the hazard relates to potential sterilization process changes rather than immediate safety risks.
Check for trays with dimensions listed in the recall: 178x135x37mm (REF: 11580A), 275x178x35mm (REF: 11580B), or 373x178x35mm (REF: 11580C). Also look for reference numbers like 39501A1 or 39501BEC.
Review the tray's dimensions and reference numbers to confirm if it is affected by this recall.
The recall is due to new 510(k) instructions for use that may require updated sterilization methods for these specific metal trays.
The hazard is low risk as the issue relates to potential sterilization process changes rather than immediate safety risks.
Check the tray's dimensions and reference numbers, such as 178x135x37mm (REF: 11580A) or 275x178x35mm (REF: 11580B).
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1991-2023 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1991-2023 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.
