Ethicon, Inc.

FDA Regulatory Profile

Summary

Total Recalls
76 (2 Class I)
510(k) Clearances
205
Inspections
14
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2605-2025Class IISTRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(August 15, 2025
Z-1096-2025Class IIPROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated fDecember 20, 2024
Z-1098-2025Class IIETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in USDecember 20, 2024
Z-1097-2025Class IIPERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use December 20, 2024
Z-0487-2025Class IIMONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in generalOctober 8, 2024
Z-0319-2025Class IICoated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358HSeptember 25, 2024
Z-2146-2024Class IIPDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including useMay 10, 2024
Z-2148-2024Class IIMONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or lMay 10, 2024
Z-2145-2024Class IIVICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approxMay 10, 2024
Z-2149-2024Class IIMONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue appMay 10, 2024
Z-2144-2024Class IIVICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligaMay 10, 2024
Z-2147-2024Class IIPDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximatioMay 10, 2024
Z-1881-2024Class IISURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.April 23, 2024
Z-1533-2024Class IISTRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRMarch 8, 2024
Z-2616-2023Class IIPDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP4August 10, 2023
Z-2617-2023Class IIPDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, DAugust 10, 2023
Z-1571-2023Class IIPDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME.March 31, 2023
Z-0480-2023Class IIPDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use iNovember 16, 2022
Z-0150-2023Class IISTRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximatiSeptember 20, 2022
Z-1773-2022Class IIPDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 ContAugust 8, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable SurgicFebruary 6, 2026
K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus KnotlesDecember 22, 2025
K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNovember 12, 2025
K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceNovember 15, 2022
K212380PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureFebruary 22, 2022
K213512DERMABOND PRINEO Skin Closure SystemDecember 7, 2021
K201996Monocryl Plus Antibacterial SutureDecember 21, 2020
K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and CatheSeptember 17, 2020
K201143VICRYL MeshAugust 6, 2020
K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceMarch 25, 2020
K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceDecember 18, 2019
K191373VICRYL MeshOctober 22, 2019
K183183VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile SyJune 27, 2019
K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless TisJanuary 10, 2019
K181652Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable SutureSeptember 28, 2018
K181151GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence SystemAugust 10, 2018
K173923Temporary Cardiac Pacing WireAugust 2, 2018
K181268PROLENE (Polypropylene) 3D PatchJuly 26, 2018
K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT ConJuly 6, 2018
K180910ULTRAPRO Mesh and ULTRAPRO ADVANCEDJuly 2, 2018