Recall archive / FDA device enforcement
SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) — FDA record Z-1385-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
- Reason
- A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 203 Units (OUS Only)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1385-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: TFL-PLS; UDI/DI: 00821925044111; All serial numbers. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 3, 2024
- Recall initiation date
- Jan 29, 2024
- Center classification date
- Mar 27, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.