Water-Jel Technologies, LLC

FDA Regulatory Profile

Water-Jel Technologies, LLC appears in FDA public data with 1 recall, 2 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0509-2026, Class III) was initiated on April 7, 2026. Its most recent 510(k) clearance was granted on January 11, 2001.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0509-2026Class IIILidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (1April 7, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K003396BURN JEL PLUSJanuary 11, 2001
K952561WATER JEL BURN KITJuly 14, 1995