Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hand Control 12FR Suction Coagulator with 10 ft cord and holster Recalled by Megadyne Medical Products, Inc. Due to Megadyne Medical Products, Inc. is voluntarily recalling Hand...
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 Megadyne Medical Products, Inc. directly.
Affected Products
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.
Quantity: 494
Why Was This Recalled?
Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.
Where Was This Sold?
This product was distributed to 7 states: FL, LA, MN, NJ, NM, PA, TX
About Megadyne Medical Products, Inc.
Megadyne Medical Products, Inc. has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report