Agency classClass IIOur severity:Severe FDA (Devices)·Z-0836-2014·Announced 2014-02-05

DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

DeRoyal Industries is recalling 409 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves reported electric shocks, which aligns with the rubric criteria for 'Severe' severity (FDA Class II with significant injury reports).

Plain-English summary

DeRoyal Industries, Inc. is recalling 409 units of the DeRoyal Aquarius Hot/Cold Therapy Combo Unit with Knee/Shoulder Blanket NS (REF T653NS). The affected units were distributed nationwide. The recall involves specific lot numbers: 32901145, 33063999, 3132641, 3217556, 33276468, 33369411, 33412431, and 33415413.

The recall is being conducted because the units display an error code for hose kinking when no kink is present and fail to monitor or control the water temperature in the blanket as intended. This malfunction could result in temperature injuries to the treatment site. Additionally, there have been two reports of electric shock associated with the device.

Consumers who possess these units should stop using them immediately and contact DeRoyal Industries, Inc. for further instructions on return or replacement.

The recalled product

Product: DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Physical Therapy
Hazard: burn-injury
electric-shock
Affected units: 409

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

Lot Numbers: 32901145
33063999
3132641
3217556
33276468
33369411
33412431
33415413

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · DeRoyal Industries Inc

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