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

NovoTHOR Gen 3.0 unit recalled because gas strut may detach from canopy

A single NovoTHOR Gen 3.0 Reg PRX unit, model S2189, is recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice states the canopy becomes difficult to lift, without describing any injury or further consequence.

Plain-English summary

The THOR NovoTHOR Gen 3.0 Reg PRX, model and catalog number S2189, UDI-DI 05060494130480, is being recalled. Only one device of this type is in scope, identified by the serial number given in the recall notice. The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and infrared spectrum to provide topical heating. The recall covers 1 unit.

The recall was issued because of 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. The FDA classified the action as Class II.

The owner of the affected unit should follow the manufacturer's instructions for inspection and repair.

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 — Light Therapy
Hazard
Affected units
1

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.

The notice also names 25 states specifically:

Part of a larger recall action

This product is one of 4 recalled by THOR Photomedicine Ltd 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.

See all 4 products in this recall →

Related recalls

Same manufacturer · THOR Photomedicine Ltd

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Same hazard · component failure

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