Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188… — Class II medical device recall Z-2416-2025
Ongoing recall by THOR Photomedicine Ltd, reported 2025-09-03, distributed nationwide. The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device
| Recall number | Z-2416-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | THOR Photomedicine Ltd, Amersham, United Kingdom |
| Recall initiated | 2025-07-24 |
| Classified | 2025-08-22 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, ES, GB, IE, IT, LT, NL, PL, RS, SK |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05060494130503 |
| Serial numbers | 4004, 4009, 4015, 4017, 4019, 4020, 4021, 4022, 4024, 4026, 4028, 4029, 4035, 4036, 4037, 4042, 4043, 4044, 4046, 4047, 4049, 4054, 4055, 4059, 4066 and 55 more |
| Model numbers | S2188 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2416-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.