NovoTHOR Whole Body Light Pod Gen 3.0 Canopy Strut Ball Stud May Fail
A ball stud on the gas strut may fail on NovoTHOR Whole Body Light Pod units, potentially causing injury if the canopy malfunctions while someone is using the device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall with no reported injuries or illnesses. The hazard is a mechanical failure (ball stud) that presents a risk of injury during normal use, but the risk remains theoretical without documented harm. Per the rubric, this qualifies as Score 3 (High) for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The NovoTHOR Whole Body Light Pod, Gen 3.0, is being recalled because the ball stud that attaches the gas strut to the canopy may fail. The affected product has three variants identified by product codes S2188 (Reg), S2189 (Reg PRX), and S2190 (XL).
If the ball stud fails, the canopy may not open or close properly. There is a potential risk of injury to users if this failure occurs while someone is inside the pod attempting to open or close the canopy.
The recall affects 61 units total: 41 distributed across US states including Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Maryland, New Jersey, New York, Oregon, Pennsylvania, Texas, Washington, and Wisconsin; and 20 units distributed internationally to Australia, Canada, Italy, Malta, Norway, Switzerland, the UAE, and the UK. Affected units can be identified by specific serial numbers associated with each product code variant.
Users of affected NovoTHOR units should stop using the device and contact THOR Photomedicine Ltd for further instructions regarding the ball stud failure issue.
The recalled product
- Product
- NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
- Manufacturer
- THOR Photomedicine Ltd
- Hazard
- mechanical-failure
- injury-risk
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03