Karl Storz recalls specific sterilization trays with outdated instructions that may affect sterilization effectiveness. Updated instructions now specify compatible endoscope sizes and exclude ethylene oxide as a sterilization method.
To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.
Karl Storz is recalling certain sterilization trays due to outdated instructions that could lead to improper sterilization. The updated instructions now specify which endoscopes can be safely used with these trays and exclude ethylene oxide as a sterilization method.
The recalled trays had outdated instructions that might not properly handle endoscopes with specific size requirements. The updated instructions now clarify that only endoscopes with lumen diameters of 1.2mm or larger and up to 845mm in length can be used, and ethylene oxide is no longer recommended as a sterilization method.
Users of Karl Storz Udel Sterilization Trays with part numbers listed in the recall notice are affected. Medical professionals using these trays for endoscopy procedures are most at risk.
Check for part numbers like 39301ACTS, 39301AS, 39301BCTS, and others listed in the recall notice. These trays were sold with instructions prior to PI-000078-10.0 (June 21, 2021).
Review the instructions for use on the tray to confirm they were issued before PI-000078-10.0 (June 21, 2021).
The recall is due to outdated instructions that could affect sterilization effectiveness. Updated instructions now specify compatible endoscope sizes and exclude ethylene oxide as a sterilization method.
Trays with part numbers like 39301ACTS, 39301AS, 39301BCTS, and others listed in the recall notice, sold with instructions prior to PI-000078-10.0 (June 21, 2021).
The recall does not require immediate action, but you should check the instructions for use to confirm they were issued before June 21, 2021. If they were, you may need to follow the updated instructions for proper sterilization.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-0442-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-0442-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
