THOR NovoTHOR XL Heating Device Recalled for Canopy Detachment Risk
THOR is recalling 55 NovoTHOR XL heating devices due to potential failure of the welded nut securing the gas strut. If the nut shears, the canopy may become difficult to lift.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a potential structural defect (welded nut failure) that could cause gas strut detachment and functional impairment of the device. No illnesses or injuries have been reported, qualifying this as a risk-of-harm situation without documented injury.
Plain-English summary
THOR Photomedicine Ltd is recalling 55 units of the NovoTHOR XL (Model S2190), a therapeutic heating device designed to emit visible and infrared energy for topical heating, intended for temporary relief of muscle and joint pain, stiffness, and minor arthritis pain.
The recall addresses a potential failure in the welded nut that secures the gas strut on the device's canopy. If the welded nut shears off, the gas strut on one side of the device becomes detached, making the canopy difficult to lift.
The recall affects 41 units distributed in the United States (including Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Massachusetts, Maryland, North Carolina, North Dakota, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia) and 14 units distributed internationally in Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, and Spain.
The recalled product
- Product
- Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature
- Manufacturer
- THOR Photomedicine Ltd
- Hazard
- structural-defect
- detachment
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 (20)
- Model/Catalog Number: S2190
- UDI-DI: 05060494130510
- Serial Numbers: 4006
- 4007
- 4008
- 4011
- 4018
- 4023
- 4025
- 4027
- 4031
- 4032
- 4034
- 4039
- 4041
- 4051
- 4052
- 4053
- 4056
- 4057
Distribution
Distributed nationwide across the United States.
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