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
- component-failure
- gas-strut
- class-ii
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
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22