The Recall Desk

Manufacturer

Thermedx LLC

2 recalls in our database name Thermedx LLC as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2015-04-29

Of the 2 recalls from Thermedx LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1463-2015·2015-04-29

    Thermedx Fluid Management System P4000 Recalled for Software Bugs

    Thermedx LLC is recalling 127 Fluid Management System P4000 units due to software bugs that could affect the accuracy of fluid deficit measurements.

    Product
    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.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2555-2014·2014-09-03

    Thermedx Fluid Management System Recalled for Canister Ring Manufacturing Change

    Thermedx LLC is recalling 21 units of the P4000 Fluid Management System because a manufacturing change to the canister ring may cause the deficit display to read higher than the actual fluid deficit.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide