CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report

NovoTHOR XL recalled by THOR Photomedicine

Thor Photomedicine is recalling NovoTHOR XL, distributed nationwide in the US. The recall was initiated on 24 Jul 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/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, 4061, 4069, 4075, 4092, 4093, 4098, 4102, 4115, 4119, 4129, 4131, 4135, 4145, 4146, 4147, 4149, 4150, 4154, 4155, 4156, 4160, 4161, 4162, 4014, 4040, 4045, 4060, 4063, 4064, 4067, 4089, 4104, 4108, 4118, 4128, 4136, 4142;

Quantity recalled55 units (41 US, 14 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2417-2025
FDA event ID: 97297
Recalling firm: Thor Photomedicine, Amersham
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jul 2025
FDA classified: 22 Aug 2025
Reported: 3 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Medical Software

Timeline

24 Jul 2025	Recall initiated by company
22 Aug 2025	Classified by FDA	+29 days
3 Sep 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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 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: No

Where it was distributed

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.

Nationwide Alaska Arizona California Colorado Connecticut Florida Georgia Hawaii Idaho Indiana Massachusetts Maryland North Carolina North Dakota New Jersey Nevada New York Oregon Pennsylvania Texas

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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, 4061, 4069, 4075, 4092, 4093, 4098, 4102, 4115, 4119, 4129, 4131, 4135, 4145, 4146, 4147, 4149, 4150, 4154, 4155, 4156, 4160, 4161, 4162, 4014, 4040, 4045, 4060, 4063, 4064, 4067, 4089, 4104, 4108, 4118, 4128, 4136, 4142;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 97297

This product is part of a recall event; the main page for the event is NovoTHOR Gen 3.0 Reg PRX recalled by THOR Photomedicine.

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025	CLASS II	NovoTHOR Gen 3.0 Reg PRX recalled by THOR Photomedicine	Thor Photomedicine	Temperature Abuse	Nationwide
3 Sep 2025	CLASS II	NovoTHOR Gen 3.0 Reg PRX recalled by THOR Photomedicine	Thor Photomedicine	Temperature Abuse	Nationwide
3 Sep 2025	CLASS II	Brand Name: Thor Product Name: NovoTHOR Model/Catalog Number: S2188 recalled	Thor Photomedicine	Temperature Abuse	Nationwide

More recalls from Thor Photomedicine

All 9

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Device	CLASS II	Brand Name: Thor Product Name: NovoTHOR Model/Catalog Number: S2188 recalled	Thor Photomedicine	Temperature Abuse	Nationwide
3 Sep 2025Device	CLASS II	NovoTHOR Gen 3.0 Reg PRX recalled by THOR Photomedicine	Thor Photomedicine	Temperature Abuse	Nationwide
3 Sep 2025Device	CLASS II	NovoTHOR Gen 3.0 Reg PRX recalled by THOR Photomedicine	Thor Photomedicine	Temperature Abuse	Nationwide
7 Feb 2024Device	CLASS II	NovoTHOR Whole Body Light Pod, Gen 3.0 Product recalled	Thor Photomedicine	Other	17 states
13 Dec 2023Device	CLASS II	NovoTHOR Gen whole body red light therapy bed recalled	Thor Photomedicine	Device Malfunction	Nationwide

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