Ethicon, Inc

San Angelo, TX, US

ETHICON, INC. appears in FDA device records in San Angelo, TX. FDA records list 208 510(k) clearances between 1976-11-03 and 2026-06-25, 448 PMA records and 7 registered establishments. As of 2026-09-10, FDA records show 104 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 208
PMA records: 448
Recall records: 104
Registered establishments: 7

510(k) clearance history

Showing 50 of 208

FDA records hold 208 510(k) clearances for Ethicon, Inc between 1976 and 2026. The busiest year on record is 1992, with 11. The most recent is 2026, with 4.

Clearances by year, as a table

510(k) clearance decisions for Ethicon, Inc, by decision year
Year	Clearances
1976	3
1977	3
1978	3
1980	7
1981	10
1982	5
1983	3
1984	7
1985	4
1986	2
1989	3
1990	1
1991	10
1992	11
1993	10
1994	7
1995	7
1996	11
1997	5
1998	5
1999	1
2000	7
2001	1
2002	3
2003	7
2004	2
2005	4
2006	6
2007	3
2008	2
2010	7
2011	2
2012	1
2013	4
2014	5
2015	5
2016	2
2017	4
2018	8
2019	4
2020	4
2021	1
2022	2
2025	2
2026	4

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K253394	Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture	GAM	Substantially Equivalent	2026-06-25
K252047	STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices	NEW	Substantially Equivalent	2026-05-18
K253572	STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device	GAW	Substantially Equivalent	2026-03-27
K253852	MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture	GAM	Substantially Equivalent	2026-02-06
K252743	STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device	GAM	Substantially Equivalent	2025-12-22
K243897	PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture	NEW	Substantially Equivalent	2025-11-12
K221744	STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device	GAM	Substantially Equivalent	2022-11-15
K212380	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture	NEW	Substantially Equivalent	2022-02-22
K213512	DERMABOND PRINEO Skin Closure System	OMD	Substantially Equivalent	2021-12-07
K201996	Monocryl Plus Antibacterial Suture	GAM	Substantially Equivalent	2020-12-21
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	OTN	Substantially Equivalent	2020-09-17
K201143	VICRYL Mesh	FTL	Substantially Equivalent	2020-08-06
K192144	STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device	NEW	Substantially Equivalent	2020-03-25
K192580	STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device	GAM	Substantially Equivalent	2019-12-18
K191373	VICRYL Mesh	FTL	Substantially Equivalent	2019-10-22
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	GAM	Substantially Equivalent	2019-06-27
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	NEW	Substantially Equivalent	2019-01-10
K181652	Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture	GAM	Substantially Equivalent	2018-09-28
K181151	GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System	PWJ	Substantially Equivalent	2018-08-10
K173923	Temporary Cardiac Pacing Wire	LDF	Substantially Equivalent	2018-08-02
K181268	PROLENE (Polypropylene) 3D Patch	FTL	Substantially Equivalent	2018-07-26
K173019	GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar	PWJ	Substantially Equivalent	2018-07-06
K180910	ULTRAPRO Mesh and ULTRAPRO ADVANCED	FTL	Substantially Equivalent	2018-07-02
K180829	PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh	FTL	Substantially Equivalent	2018-06-28
K173162	GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide	PWJ	Substantially Equivalent	2018-06-28
K170767	Surgical Stainless Steel Suture, Stainless Steel Suture	GAQ	Substantially Equivalent	2017-11-01
K172089	PROLENE Soft Polypropylene Mesh	FTL	Substantially Equivalent	2017-10-05
K163645	DERMABOND PRINEO Skin Closure System	OMD	Substantially Equivalent	2017-04-21
K163152	PROLENE Soft Polypropylene Mesh	FTL	Substantially Equivalent	2017-03-11
K161726	E-Pack Procedure Kit	GAM	Substantially Equivalent	2016-07-12
K153611	Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device	GAM	Substantially Equivalent	2016-06-03
K152490	DERMABOND PRINEO Skin Closure System	OMD	Substantially Equivalent	2015-11-25
K152096	DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive	MPN	Substantially Equivalent	2015-10-22
K151200	STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device	GAM	Substantially Equivalent	2015-08-13
K150670	STRATAFIX Spiral PDS Plus Knotless Tissue Control Device	NEW	Substantially Equivalent	2015-07-02
K142822	PLIASURE Polyglycolide Synthetic Absorbable Suture	GAM	Substantially Equivalent	2015-03-26
K141560	ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE	FTL	Substantially Equivalent	2014-10-23
K141776	STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES	NEW	Unknown	2014-10-15
K133198	ULTRAPRO COMFORT PLUG	FTL	Substantially Equivalent	2014-05-30
K133864	DERMABOND PRINEO SKIN CLOSURE SYSTEM	OMD	Substantially Equivalent	2014-03-10
K132580	COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE	GAM	Substantially Equivalent	2014-02-28
K133356	PROLENE POLYPROPYLENE NONABSORBABLE SUTURE	GAW	Substantially Equivalent	2013-12-06
K131656	MORCELLEX SIGMA GENERATOR	HET	Substantially Equivalent	2013-09-27
K132054	GYNECARE TVT EXACT CONTINENCE SYSTEM	OTN	Substantially Equivalent	2013-08-23
K123114	ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE	GDW	Substantially Equivalent	2013-02-05
K113205	ARTISYN Y-SHAPED MESH	OTO	Substantially Equivalent	2012-06-11
K113004	PDS(TM) BARBED SUTURES	NEW	Substantially Equivalent	2011-12-20
K111751	VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS	HIN	Substantially Equivalent	2011-12-02
K100936	GYNECARE TVT ABBREVO CONTINENCE SYSTEM	OTN	Substantially Equivalent	2010-07-01
K100423	DERMABOND NX ADHESIVE MODEL: DNX6, DNX12	MPN	Substantially Equivalent	2010-05-04

Registered establishments

FDA registered establishments for Ethicon, Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1614993	1614993	ETHICON, INC.	3348 PULLIAM ST., SAN ANGELO, TX 76905 US	2026	DXZ FTL FZP GAM GAN NEW
2210968	2210968	ETHICON, INC.	ROUTE 22 WEST, P.O. Box 151, Somerville, NJ 08876 US	2026	DXZ FOD FTL FZP GAL GAM GAN GAO GAP GAQ and 20 more, listed in full below
3006638824	3006638824	ETHICON, INC.	Calle Durango No. 2751, CIUDAD JUAREZ Chihuahua C.P. 32575 MX	2026	DXZ FCZ FOD FZX GAB GAL GAM GAN GAP GAQ and 26 more, listed in full below
3017102971	3017102971	ETHICON, INC.	1000 Route 202, Raritan, NJ 08869 US	2026	DXZ FOD FTL FZP GAL GAM GAN GAO GAP GAQ and 22 more, listed in full below
3007791599	3007791599	ETHICON, LLC	475 C Street, Guaynabo, PR 00969 US	2026	DXZ FOD GAL GAM GAN GAP GAQ GAR GAT GAW and 6 more, listed in full below
2648650	2648650	ETHICON, LLC.	Highway 183 Km. 8.3, San Lorenzo, PR 00754 US	2026	DXZ FTL GAL GAM GAP GAQ GAR GAT GAW HDH and 8 more, listed in full below
3032543753	3032543753	Ethicon LLC	PR-2, Km 45.6, Manati, PR 00674 US	2026	GAL GAM GAP GAQ GAR GAT GAW

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Showing 25 of 104

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2605-2025	STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.	Potential for barb non-engagement.	Class II	2025-08-15	Open, Classified
Z-1098-2025	ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US	Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.	Class II	2024-12-20	Open, Classified
Z-1097-2025	PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.	Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.	Class II	2024-12-20	Open, Classified
Z-1096-2025	PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.	Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.	Class II	2024-12-20	Open, Classified
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.	Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.	Class II	2024-10-08	Open, Classified
Z-0319-2025	Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H	Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.	Class II	2024-09-25	Open, Classified
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	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .	Class II	2024-05-10	Open, Classified
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	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .	Class II	2024-05-10	Open, Classified
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	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .	Class II	2024-05-10	Open, Classified
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	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .	Class II	2024-05-10	Open, Classified
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	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .	Class II	2024-05-10	Open, Classified
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	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .	Class II	2024-05-10	Open, Classified
Z-1881-2024	SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.	Some applicator tips from these lots had open seals.	Class II	2024-04-23	Open, Classified
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	Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility	Class II	2024-03-08	Open, Classified
Z-2617-2023	PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z421H-50, Z421H-50, Z421H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z423H-50, Z423H-50, Z423H-50, Z442H-50, Z442H-50, Z442H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z489G-50, Z489G-50, Z489G-50, Z489G-50, Z493G-50, Z493G-50, Z493G-50, Z493G-50, Z493G-50, Z494G-50, Z495G-05, Z495G-05, Z495G-05, Z496G-50, Z496G-50, Z496G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z503G-50, Z504G-50, Z507G-50, Z507G-50, Z683G-05, Z833G-05, Z833G-05, Z844G-50	Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.	Class II	2023-08-10	Open, Classified
Z-2616-2023	PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40, PDP9715H15, PDP9715H40, PDP9733H16, PDP9861H40, PDP9865H40, XWPDP421H40, XWPDP423H40, XWPDP442H40, XWPDP443H16	Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.	Class II	2023-08-10	Open, Classified
Z-1571-2023	PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H	Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved	Class II	2023-03-31	Open, Classified
Z-0480-2023	PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery	knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage	Class II	2022-11-16	Open, Classified
Z-0150-2023	STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12	Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair	Class II	2022-09-20	Open, Classified
Z-1773-2022	PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles	Product may contain the incorrect material which could impact treatment.	Class II	2022-08-08	Open, Classified
Z-1053-2022	STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].	Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.	Class II	2022-03-24	Open, Classified
Z-0953-2021	Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12	Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach	Class II	2021-01-04	Terminated
Z-0533-2021	PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm	The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.	Class II	2020-10-23	Terminated
Z-0116-2021	VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G	Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles	Class II	2020-09-09	Terminated
Z-2486-2020	PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870	Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years	Class II	2020-06-10	Open, Classified

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Data as of 2026-09-28, FDA export datePage updated 2026-09-06Source: openFDA, public domain