FDA Device recall Z-2416-2025
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL…
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL… by Thor Photomedicine, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2416-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-24 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Thor Photomedicine |
| Distribution | US |
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
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.
Identifiers
| code_info | Model/Catalog Number: S2188; UDI-DI: 05060494130503; Serial Numbers: 4004, 4015, 4017, 4019, 4021, 4022, 4024, 4026, 40…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2416-2025%22
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