Class II U.S. Food and Drug Administration

Brand Name: Thor Product Name: NovoThor Model/ recall: The potential for a failed welded nut to shear off. When this occurs

Recall published 1+ years ago

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 hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2416-2025
Published
September 3, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
THOR Photomedicine Ltd
Product type
Medical devices
Units affected
80 units (66 US, 14 OUS)
Distribution
Nationwide
Made in
United Kingdom
Lot / code info
Model/Catalog Number: S2188; UDI-DI: 05060494130503; Serial Numbers: 4004, 4015, 4017, 4019, 4021, 4022, 4024, 4026, 4028, 4029, 4035, 4036, 4037, 4042, 4043, 4044, 4046, 4047, 4049, 4054, 4055, 4059, 4066, 4071, 4072, 4073, 4074, 4076, 4077, 4078, 4079, 4082, 4083, 4084, 4085, 4086, 4087, 4088, 4090, 4091, 4094, 4095, 4097, 4099, 4101, 4105, 4106, 4111, 4112, 4114, 4116, 4117, 4121, 4123, 4124, 4125, 4126, 4130, 4140, 4141, 4143, 4144, 4151, 4153, 4157, 4158, 4009, 4020, 4103, 4107, 4109, 4110, 4113, 4120, 4122, 4127, 4133, 4134, 4138, 4139;
UPC codes
05060494130503

Products covered by this recall

Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 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

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05060494130503

Model or item number

On the rating label, the box or the instruction sheet.

  • S2188 Software Version
  • S2188

Serial number

On the rating plate, often next to the date of manufacture.

  • 4004
  • 4015
  • 4017
  • 4019
  • 4021
  • 4022
  • 4024

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

THOR Photomedicine Ltd — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: THOR Photomedicine Ltd — 2 Anglo Office Park, Amersham

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was THOR Photomedicine Ltd medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05060494130503; model number S2188 Software Version, S2188. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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