Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to Recalled by Steris Corporation Due to Two electronic diode components (D1 & D4) placed...
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 Steris Corporation directly.
Affected Products
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001
Quantity: 5 units
Why Was This Recalled?
Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Steris Corporation
Steris Corporation has 109 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report