The Recall Desk
HighFDA (Devices)·Z-2418-2025·Announced 2025-09-03

THOR NovoTHOR Gen 3.0 Light Therapy Device Canopy Failure

THOR Photomedicine recalls the NovoTHOR Gen 3.0 light therapy device due to faulty welded nuts that can shear off, detaching the gas strut and making the canopy 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 medical device recall for a mechanical failure that impairs device function. The source text does not report any actual injuries or illnesses, only a risk-of-harm condition where structural failure makes the device difficult to operate. Per the rubric, a risk-of-harm product without reported injury receives a High (3) classification.

Plain-English summary

THOR Photomedicine Ltd is recalling the NovoTHOR Gen 3.0 (Model S2189), a medical device designed to emit visible and infrared energy for therapeutic heating and temporary pain relief.

The device may contain welded nuts that can fail and shear off, causing the gas strut on one side of the canopy to detach. When this occurs, users may find the canopy difficult or impossible to lift, impairing the device's usability.

The recalled device has been distributed worldwide, including throughout the United States (AK, AZ, CA, CO, CT, FL, GA, HI, ID, IN, MA, MD, NC, ND, NJ, NV, NY, OR, PA, TX, UT, VA, WA, WI, WV) and internationally (Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain).

Users who own this device should contact THOR Photomedicine for guidance. If you have experienced difficulty opening the canopy or suspect a weld failure, discontinue use and reach out to the manufacturer.

The recalled product

Product
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 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 tissu
Manufacturer
THOR Photomedicine Ltd
Category
Medical Device — Therapeutic Device
Hazard
  • weld-failure
  • mechanical-failure

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)

  • Model/Catalog Number: S2189
  • UDI-DI: 05060494130480
  • Only one device of this type is in scope. Serial number: 4068

Distribution

Distributed nationwide across the United States.

Related recalls

Same category