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Ethicon Inc.

United States·US-MF-000013111

Last updated September 17, 2026

Information

Country: United States
Address: 1000 Route 202, Raritan, New Jersey, United States
Website: its.jnj.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(877)384-4266
PRRC Contact: Linda Plews
EUDAMED SRN: US-MF-000013111
FDA FEI Number: 3007791599
DUNS Number: 002144145

Catalogue (5835)

Page 19 of 117

Device	Model / Reference	Registries	Class	Status
Pds	ZB751D	FDA UDI	Class II	Active
Monocryl	Y442H	FDA UDI	Class II	Unknown
Coated VICRYL	J838D	FDA UDI	Class II	Active
Monocryl	D10041	FDA UDI	Class II	Active
Ethicon	812H	FDA UDI	Class II	Active
Prolene	D6609	FDA UDI	Class II	Active
Mersilene	D8125	FDA UDI	Class II	Active
E-Pack	7435E	FDA UDI	Class II	Unknown
Ethicon	CC41G	FDA UDI	Class II	Active
Prolene	EPM8736	FDA UDI	Class II	Active
Ethicon	D1904	FDA UDI	Class II	Active
E-Pack	8440E	FDA UDI	Class II	Unknown
E-Pack	8856E	FDA UDI	Class II	Unknown
Ethicon	1798G	FDA UDI	Class II	Active
Ethilon	1663G	FDA UDI	Class II	Active
Prolene	M8705	FDA UDI	Class II	Active
Ethicon	805H	FDA UDI	Class II	Active
Coated VICRYL	VCP304H	FDA UDI	Class II	Unknown
Coated VICRYL	D7818	FDA UDI	Class II	Active
E-Pack	8550E	FDA UDI	Class II	Unknown
Pds	D10059	FDA UDI	Class II	Active
Ethibond Excel	X31044H	FDA UDI	Class II	Active
Coated VICRYL	J510G	FDA UDI	Class II	Active
Ethilon	F24022H	FDA UDI	Class II	Active
Ethilon	1662G	FDA UDI	Class II	Active
Ethibond Excel	SXP76	FDA UDI	Class II	Active
Coated VICRYL	J318H	FDA UDI	Class II	Active
E-Pack	7607E	FDA UDI	Class II	Unknown
E-Pack	9584E	FDA UDI	Class II	Unknown
Ethibond Excel	X425H	FDA UDI	Class II	Active
Prolene	8730H	FDA UDI	Class II	Active
Coated VICRYL	D8543	FDA UDI	Class II	Active
Coated VICRYL	D8876	FDA UDI	Class II	Active
Ethilon	664G	FDA UDI	Class II	Active
Ethilon	2830G	FDA UDI	Class II	Active
Coated VICRYL	J324H	FDA UDI	Class II	Active
Stratafix	SXPP2B408	FDA UDI	Class II	Active
E-Pack	8046E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP738D	FDA UDI	Class II	Active
Pds	PDP316H	FDA UDI	Class II	Active
Coated VICRYL	J346H	FDA UDI	Class II	Active
Ethicon	D9604	FDA UDI	Class II	Active
Ethilon	D3997	FDA UDI	Class II	Active
Prolene	D7343	FDA UDI	Class II	Active
Prolene	8845G	FDA UDI	Class II	Active
Monocryl	MCPB345H	FDA UDI	Class II	Unknown
Ethibond Excel	D10048N	FDA UDI	Class II	Active
Ethibond Excel	X976H	FDA UDI	Class II	Active
E-Pack	9598E	FDA UDI	Class II	Unknown
Stratafix	SXPP2B102	FDA UDI	Class II	Active

Related Companies

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Notified Bodies

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Authorities

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FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 15, 2025	Z-2605-2025	—	open, classified	Potential for barb non-engagement.
Dec 20, 2024	Z-1096-2025	—	open, classified	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.
Dec 20, 2024	Z-1097-2025	—	open, classified	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.
Dec 20, 2024	Z-1098-2025	—	open, classified	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.
Sep 25, 2024	Z-0319-2025	—	open, classified	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.
May 10, 2024	Z-2145-2024	—	open, classified	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
May 10, 2024	Z-2147-2024	—	open, classified	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
May 10, 2024	Z-2149-2024	—	open, classified	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
May 10, 2024	Z-2144-2024	—	open, classified	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
May 10, 2024	Z-2148-2024	—	open, classified	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
May 10, 2024	Z-2146-2024	—	open, classified	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Mar 8, 2024	Z-1533-2024	—	open, classified	Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Aug 10, 2023	Z-2616-2023	—	open, classified	Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Aug 10, 2023	Z-2617-2023	—	open, classified	Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Mar 31, 2023	Z-1571-2023	—	open, classified	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

FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Ethicon, Inc. Somerville, NJ · US FEI 2210968
Ethicon, Inc. CIUDAD JUAREZ Chihuahua · MX FEI 3006638824