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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 9 of 117

Device	Model / Reference	Registries	Class	Status
E-Pack	9954E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP437H	FDA UDI	Class II	Active
Coated VICRYL	J822G	FDA UDI	Class II	Active
Prolene	M8743	FDA UDI	Class II	Active
Prolene	D8581	FDA UDI	Class II	Active
E-Pack	9713E	FDA UDI	Class II	Unknown
Coated VICRYL	J582G	FDA UDI	Class II	Active
Coated VICRYL	D7246	FDA UDI	Class II	Active
Nurolon	C545D	FDA UDI	Class II	Active
Ethibond Excel	D8944	FDA UDI	Class II	Active
Ethicon	794G	FDA UDI	Class II	Active
Coated VICRYL	J871H	FDA UDI	Class II	Active
Pds	D7185	FDA UDI	Class II	Active
Ethilon	662H	FDA UDI	Class II	Active
Ethilon	1661G	FDA UDI	Class II	Active
Monocryl	Y944H	FDA UDI	Class II	Active
Ethibond Excel	PXX92SCN	FDA UDI	Class II	Active
Ethibond Excel	D10070	FDA UDI	Class II	Active
Ethicon	D7005	FDA UDI	Class II	Active
E-Pack	8332E	FDA UDI	Class II	Unknown
Ethicon	450G	FDA UDI	Class I	Unknown
Ethibond Excel	D8793	FDA UDI	Class II	Active
E-Pack	9684E	FDA UDI	Class II	Unknown
Monocryl	Y931H	FDA UDI	Class II	Active
Ethilon	F2419H	FDA UDI	Class II	Active
E-Pack	5238E	FDA UDI	Class II	Unknown
Ethilon	2829G	FDA UDI	Class II	Active
Coated VICRYL	J591G	FDA UDI	Class II	Active
Ethibond Excel	D9301	FDA UDI	Class II	Active
E-Pack	6386E	FDA UDI	Class II	Unknown
E-Pack	8633E	FDA UDI	Class II	Unknown
Ethilon	W345BG	FDA UDI	Class II	Active
Lapra-Ty	XC200	FDA UDI	Class II	Active
Ethibond Excel	X306H	FDA UDI	Class II	Active
E-Pack	9553E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP840D	FDA UDI	Class II	Active
E-Pack	8733E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP347H	FDA UDI	Class II	Unknown
Coated VICRYL	J670G	FDA UDI	Class II	Active
Stratafix	SXPP2B412	FDA UDI	Class II	Active
Ethicon	852H	FDA UDI	Class II	Active
Stratafix	SXPP2B401	FDA UDI	Class II	Active
Pds	PDP663H	FDA UDI	Class II	Active
Coated VICRYL	J415H	FDA UDI	Class II	Active
Coated VICRYL	D8003	FDA UDI	Class II	Active
Ethibond Excel	D8424	FDA UDI	Class II	Active
Ethicon	893H	FDA UDI	Class II	Active
E-Pack	7721E	FDA UDI	Class II	Unknown
E-Pack	8627E	FDA UDI	Class II	Unknown
Ethibond Excel	SXX86N	FDA UDI	Class II	Active

Related Companies

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Importers

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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