Tecfen Medical

FDA Regulatory Profile

Tecfen Medical appears in FDA public data with 7 recalls, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1955-2025, Class II) was initiated on April 25, 2025.

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1955-2025Class IIBrand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 SApril 25, 2025
Z-1954-2025Class IIBrand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog NumberApril 25, 2025
Z-1953-2025Class IIBrand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog NumApril 25, 2025
Z-1951-2025Class IIBrand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 SApril 25, 2025
Z-1952-2025Class IIBrand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 SApril 25, 2025
Z-1950-2025Class IIBrand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 SApril 25, 2025
Z-1949-2025Class IIBrand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 SoftwApril 25, 2025