Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar Recalled by Dannoritzer Medizintechnik GmbH & Co. KG Due to The Manual cleaning process and the usability of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dannoritzer Medizintechnik GmbH & Co. KG directly.
Affected Products
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dannoritzer Medizintechnik GmbH & Co. KG
Dannoritzer Medizintechnik GmbH & Co. KG has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report