Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: Recalled by Applied Medical Resources Corp Due to Potential to improperly characterize tissue within the jaws,...
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 Applied Medical Resources Corp directly.
Affected Products
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.
Quantity: 101 units (U.S) and 38 units (International)
Why Was This Recalled?
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Applied Medical Resources Corp
Applied Medical Resources Corp has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report