ETHICON, Inc.
ETHICON, Inc. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2026, with 70 FDA device recalls on record.
Top product codes for ETHICON, Inc.
FDA recalls by ETHICON, Inc.
10 most recent of 70- Z-0487-2025 — MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
- Z-0319-2025 — Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
- Z-2148-2024 — MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
- Z-2146-2024 — PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
- Z-2145-2024 — VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H
- Z-2144-2024 — VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H
- Z-2147-2024 — PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H
- Z-2149-2024 — MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13
- Z-1881-2024 — SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
- Z-1533-2024 — STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by ETHICON, Inc.
1–100 of 205- K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
- K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
- K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
- K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
- K221744 — STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
- K213512 — DERMABOND PRINEO Skin Closure System
- K201996 — Monocryl Plus Antibacterial Suture
- K201686 — GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide
- K201143 — VICRYL Mesh
- K192144 — STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
- K192580 — STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
- K191373 — VICRYL Mesh
- K183183 — VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
- K182873 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
- K181652 — Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
- K181151 — GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
- K173923 — Temporary Cardiac Pacing Wire
- K181268 — PROLENE (Polypropylene) 3D Patch
- K173019 — GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
- K180910 — ULTRAPRO Mesh and ULTRAPRO ADVANCED
- K173162 — GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
- K180829 — PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
- K170767 — Surgical Stainless Steel Suture, Stainless Steel Suture
- K172089 — PROLENE Soft Polypropylene Mesh
- K163152 — PROLENE Soft Polypropylene Mesh
- K161726 — E-Pack Procedure Kit
- K152490 — DERMABOND PRINEO Skin Closure System
- K152096 — DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
- K151200 — STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K150670 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
- K142822 — PLIASURE Polyglycolide Synthetic Absorbable Suture
- K141560 — ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
- K141776 — STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
- K133198 — ULTRAPRO COMFORT PLUG
- K133864 — DERMABOND PRINEO SKIN CLOSURE SYSTEM
- K132580 — COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
- K133356 — PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
- K131656 — MORCELLEX SIGMA GENERATOR
- K132054 — GYNECARE TVT EXACT CONTINENCE SYSTEM
- K123114 — ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
- K113205 — ARTISYN Y-SHAPED MESH
- K113004 — PDS(TM) BARBED SUTURES
- K111751 — VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
- K100936 — GYNECARE TVT ABBREVO CONTINENCE SYSTEM
- K100423 — DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
- K093845 — ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
- K100280 — GYNCARE MORCELLEX TISSUE MORCELLATOR
- K100485 — GYNECARE TVT EXACT CONTINENCE SYSTEM
- K092590 — PDS PLATES
- K082216 — TBD ETHICON MESH
- K071512 — GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
- K071249 — ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
- K070224 — ULTRAPRO PLUG
- K063562 — GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
- K061533 — PROCEED VENTRAL PATCH
- K061037 — PDS PLUS ANTIBACTERIAL SUTURE
- K061050 — GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
- K060713 — PROCEED SURGICAL MESH
- K052999 — SEMPERFLO INFUSION SYSTEM
- K052953 — NUVANCE* FACIAL REJUVENATION SYSTEM
- K052401 — GYNECARE TVT SECUR SYSTEM
- K051701 — VICRYL * MESH BAG
- K051732 — ENDOSCOPIC APPLICATOR
- K050845 — MONOCRYL PLUS ANTIBACTERIAL SUTURE
- K042603 — GYNECARE PROLENE FASTENER SYSTEM
- K033337 — ULTRAPRO MESH
- K033746 — MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
- K033568 — GYNECARE TVT OBTURATOR SYSTEM
- K032420 — MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
- K031925 — PROCEED TRILAMINATE SURGICAL MESH
- K032339 — CARDIOVATIONS PORTABLE VIDEO SYSTEM
- K031846 — CARDIOVATIONS OPTICAL BIPOLAR DEVICE
- K031847 — CARDIOVATIONS RETRACTOR
- K022715 — COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
- K023880 — CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
- K022269 — COATED VICRYL* (POLYGLACTIN 910) SUTURE
- K010722 — PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
- K003587 — CLEARGLIDE PRECISION BIPOLAR DEVICE
- K002672 — VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
- K003070 — ETHIBOND EXCEL VALVE LOOP SUTURE
- K001625 — PRONOVA NONABSORBABLE SUTURE, USP
- K001122 — PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
- K993801 — GYNECARE LAPAROSCOPIC MORCELLATOR
- K994418 — VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
- K984220 — MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
- K981361 — POWERSTAR BIPOLAR SCISSORS
- K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
- K980503 — TEMPORARY CARDIAC PACING WIRE
- K974299 — PANACRYL
- K974098 — PUBOUURETHRAL SLING
- K973384 — ETHICON NON-STICK BIPOLAR FORCEPS
- K973173 — POWERSTAR BIPOLAR SCISSORS
- K972412 — PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
- K970896 — MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
- K970317 — MODIFIED E-PACK PROCEDURE KIT
- K964072 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
- K964345 — ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED
Data sourced from openFDA. This site is unofficial and independent of the FDA.