Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fluid Management System P4000 Recalled by Thermedx LLC Due to To correct software bugs that could affect 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 Thermedx LLC directly.
Affected Products
Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
Quantity: 127 units
Why Was This Recalled?
To correct software bugs that could affect the ability to accurately measure fluid deficit.
Where Was This Sold?
This product was distributed to 11 states: IL, LA, MA, MI, MS, NY, NC, OH, TX, WA, WV
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