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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97297

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 24, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
THOR Photomedicine Ltd

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-2416-2025
Recall number
Z-2416-2025
Initiated
July 24, 2025
Classification
Class II
Status
Ongoing
Recalling firm
THOR Photomedicine Ltd
Quantity
80 units (66 US, 14 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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;

Distribution pattern

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.

device · product 2 of 4

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

Z-2417-2025
Recall number
Z-2417-2025
Initiated
July 24, 2025
Classification
Class II
Status
Ongoing
Recalling firm
THOR Photomedicine Ltd
Quantity
55 units (41 US, 14 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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;

Distribution pattern

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.

device · product 3 of 4

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 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: N/A

Z-2418-2025
Recall number
Z-2418-2025
Initiated
July 24, 2025
Classification
Class II
Status
Ongoing
Recalling firm
THOR Photomedicine Ltd
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model/Catalog Number: S2189; UDI-DI: 05060494130480; Only one device of this type is in scope. Serial number: 4068;

Distribution pattern

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.

device · product 4 of 4

Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 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: N/A

Z-2419-2025
Recall number
Z-2419-2025
Initiated
July 24, 2025
Classification
Class II
Status
Ongoing
Recalling firm
THOR Photomedicine Ltd
Quantity
2 units (1 US, 1 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model/Catalog Number: S2186; UDI-DI: Serial numbers: 4005, 4062;

Distribution pattern

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.