# FDA recall Z-2419-2025

> **THOR Photomedicine Ltd** · Class II · device recall initiated 2025-07-24.

## Product

Brand Name: THOR  Product Name: NovoTHOR Gen 3.0 Reg PRX  Model/Catalog Number: S2186  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 for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles.  Component: N/A

## Reason for recall

The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.

## Distribution

Worldwide distribution: US (nationwide): 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 OUS (International): Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain.

## Key facts

- **Recall number:** Z-2419-2025
- **Recalling firm:** THOR Photomedicine Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-24
- **Report date:** 2025-09-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Amersham, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2419-2025

## Citation

> AI Analytics. FDA recall Z-2419-2025. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-2419-2025. Source: US FDA. Licensed CC0.

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