MERCHSOURCE LLC

FDA Regulatory Profile

MERCHSOURCE LLC appears in FDA public data with 1 recall, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1661-2022, Class II) was initiated on August 1, 2022. Its most recent 510(k) clearance was granted on October 30, 2025.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1661-2022Class IIThe product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lAugust 1, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K251531AIR COMPRESSION BOOTS 1018195,1018196October 30, 2025
K252093Light Therapy Mask (1019055)October 16, 2025
K252096Light Therapy Decollete Mask (1019135)October 1, 2025