DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure
DeRoyal Industries is recalling 25 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 involves a medical device with reported electric shocks and a risk of temperature injuries, which aligns with the rubric criteria for significant injury reports or high-risk device defects.
Plain-English summary
DeRoyal Industries, Inc. is recalling 25 units of the DeRoyal Aquarius Hot/Cold Therapy Combo Unit with Foot/Ankle Blanket NS (REF T656NS). The affected units were distributed nationwide. The specific lot numbers involved are 32901129, 32980912, 33015541, 33024746, and 33105239.
The recall is due to a defect where the unit displays an error code for hose kinking even when no kink is present. Additionally, the unit fails to monitor the temperature of the water in the blanket as intended and does not control it through the automatic temperature control system. This failure could result in temperature injuries to the treatment site. There have also been two reports of electric shock associated with these units.
Consumers who possess these specific units should stop using them immediately and contact DeRoyal Industries, Inc. for instructions on how to return or dispose of the product.
The recalled product
- Product
- DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 25
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 (5)
- Lot Numbers: 32901129
- 32980912
- 33015541
- 33024746
- 33105239
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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