Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization Recalled by Instrumed International, Inc. Due to Additional caution statements have been added to the...
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 Instrumed International, Inc. directly.
Affected Products
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
Quantity: 65 instruments
Why Was This Recalled?
Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Instrumed International, Inc.
Instrumed International, Inc. has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report