Sklar Instruments

FDA Regulatory Profile

Summary

Total Recalls
30
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0939-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,ModeDecember 3, 2024
Z-0953-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model NumberDecember 3, 2024
Z-0946-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25MDecember 3, 2024
Z-0940-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, MoDecember 3, 2024
Z-0945-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, ModDecember 3, 2024
Z-0927-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model NumDecember 3, 2024
Z-0937-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, ModDecember 3, 2024
Z-0930-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, December 3, 2024
Z-0928-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, MoDecember 3, 2024
Z-0932-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5,December 3, 2024
Z-0942-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, ModDecember 3, 2024
Z-0938-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10,December 3, 2024
Z-0954-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25,December 3, 2024
Z-0935-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, December 3, 2024
Z-0925-2025Class IIECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRDecember 3, 2024
Z-0943-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25,December 3, 2024
Z-0944-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, MoDecember 3, 2024
Z-0949-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, MoDecember 3, 2024
Z-0947-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10,December 3, 2024
Z-0936-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50,December 3, 2024