DeRoyal Industries Inc: Medical Device Recall in 2014 - (Recall #: Z-0834-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.

Product Classification:

Class II

Date Initiated: September 17, 2013

Date Posted: February 5, 2014

Recall Number: Z-0834-2014

Event ID: 66742

Reason for Recall:

The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.

Status: Terminated

Product Quantity: 738 units

Code Information:

Lot Numbers: 31480713, 31480721, 31968743, 31971619, 31990844, 32005711, 32018491, 32037764, 32118020, 32710832, 32736223, 33053264, 33105221, 33141176, 33164204, 33164407, 33276273, 33329911

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated