Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Thermedx Fluid Management System is designed to provide irrigation Recalled by Thermedx LLC Due to A vendor changed the manufacturing process of a...
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 Thermedx LLC directly.
Affected Products
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
Quantity: 21
Why Was This Recalled?
A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Thermedx LLC
Thermedx LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report