RegWardenFDA facility compliance records
Company

THOR Photomedicine Ltd

3 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2022: 1 recalls; 2023: 1 recalls; 2025: 1 recalls2017201820192020202112022120232024120252026
  • Recalls (3)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2025-07-24
    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.
  • Class IIOngoing2023-11-20
    One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy
  • Class IIOngoing2022-09-13
    Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “THOR Photomedicine Ltd — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9054807-thor-photomedicine-ltd/

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