The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2417-2025·Announced 2025-09-03

NovoTHOR XL devices recalled over failed welded nut detaching gas strut

NovoTHOR XL devices, model S2190, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 55 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 XL, model and catalog number S2190, UDI-DI 05060494130510, is being recalled. Affected units are identified by serial numbers including 4006, 4007, 4008, 4011, 4018, 4023 and 4025, with the full list 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 55 units, of which 41 are in the United States and 14 outside it.

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.

Owners of affected units should follow the manufacturer's instructions for inspection and repair.

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…
Manufacturer
THOR Photomedicine Ltd
Category
Medical Device — Light Therapy
Hazard

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.

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 →

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