Dannoritzer recalls laparoscopy instruments instructions for use due to unvalidated manual cleaning process. The recall addresses safety risks from improper reprocessing.
The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.
Dannoritzer is recalling laparoscopy instruments instructions for use because the manual cleaning process wasn't validated. This could lead to improper reprocessing and potential safety risks for users.
The instructions for use didn't validate the manual cleaning process. This means users might reprocess instruments incorrectly, potentially causing safety issues during medical procedures.
Medical professionals using laparoscopy instruments may be affected. Those handling the instruments without proper reprocessing instructions are at higher risk.
Check for laparoscopy instruments with the instructions for use (IFU) mentioning monopolar electrode, insert, or forceps/scissors for electrosurgical coagulation. The recall covers specific components used in surgical procedures.
Check if your laparoscopy instruments have the updated instructions for use (IFU) that address manual cleaning.
The manual cleaning process and reprocessing instructions weren't validated, which could lead to improper instrument handling.
Review the updated instructions for use (IFU) to ensure proper reprocessing methods are followed.
The recall does not specify a deadline for action.
We’ve drafted a message you can send Dannoritzer to request your refund or repair — edit it as you like.
Subject: Recall Z-0062-2019 — Dannoritzer Dannoritzer Hello, I own a Dannoritzer that is covered by recall Z-0062-2019 from Dannoritzer. 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.
