Ethicon Endo Surgery, LLC

FDA Regulatory Profile

Ethicon Endo Surgery, LLC appears in FDA public data with 4 recalls, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1515-2025, Class II) was initiated on March 7, 2025. Its most recent 510(k) clearance was granted on August 29, 2023.

Summary

Total Recalls
4
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1515-2025Class IIPROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRMMarch 7, 2025
Z-1514-2025Class IIPDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1March 7, 2025
Z-1516-2025Class IIETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MHMarch 7, 2025
Z-1513-2025Class IIPDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MPMarch 7, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K232313LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating MultAugust 29, 2023
K050344LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIERMarch 14, 2005