Z-0838-2014Class II

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only...

Name: Z-0838-2014 DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only...
Creator: DeRoyal Industries Inc
Published: 2013-09-17
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2013-09-17 / Terminated / root cause: design

FDA source

DeRoyal Industries Inc began a recall of DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane... on 2013-09-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0838-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-17
Posted: 2014-01-27
Terminated: 2017-06-05
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Product code: ILO Pack, Hot Or Cold, Water Circulating
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.
Root cause tag: design
FDA root cause: Device Design
Action: DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in commerce: 2 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot Number: 32871812

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0838-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0834-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27
Z-0835-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27
Z-0836-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27
Z-0837-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27
Z-0838-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27
Z-0839-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27

Product code ILO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)