DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure
DeRoyal Industries is recalling 121 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.
What this means for you
Illness, injury, or structural failure has been reported. 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 and potential temperature injuries, meeting the criteria for a Severe rating (score 4) due to significant injury reports.
Plain-English summary
DeRoyal Industries, Inc. is recalling 121 units of the DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS. The affected units are prescription-only medical devices used for physical therapy. The recall covers units with lot numbers 32871821, 32976471, and 33105247, which were distributed nationwide.
The recall is due to a defect where the unit displays an error code for hose kinking when no kink is present. More critically, the unit fails to monitor the temperature of the water in the blanket as intended and fails to control it through the automatic temperature control system. This malfunction could result in temperature injuries to the treatment site. Additionally, there have been two reports of electric shock associated with these units.
Consumers and healthcare facilities should stop using the affected units immediately. The recall is classified as Class II by the FDA. Users should contact DeRoyal Industries for further instructions on returning or replacing the devices.
The recalled product
- Product
- DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 121
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 (3)
- Lot Numbers: 32871821
- 32976471
- 33105247
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.
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