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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 6 of 117

Device	Model / Reference	Registries	Class	Status
Stratafix	SXMP1B119	FDA UDI	Class II	Active
Coated VICRYL	J571G	FDA UDI	Class II	Active
Prolene	2795G	FDA UDI	Class II	Active
Ethicon	3803T	FDA UDI	Class II	Active
Prolene	8757H	FDA UDI	Class II	Active
E-Pack	5228E	FDA UDI	Class II	Unknown
Coated VICRYL	J401G	FDA UDI	Class II	Active
Ethicon	883H	FDA UDI	Class II	Active
E-Pack	9547E	FDA UDI	Class II	Unknown
E-Pack	9612E	FDA UDI	Class II	Unknown
Ethibond Excel	D8363	FDA UDI	Class II	Active
Pronova	PN3762H	FDA UDI	Class II	Active
Pds	Z824G	FDA UDI	Class II	Active
Coated VICRYL	D6677	FDA UDI	Class II	Active
E-Pack	6981E	FDA UDI	Class II	Unknown
Ethicon	1793G	FDA UDI	Class II	Active
Prolene	7761G	FDA UDI	Class II	Active
Monocryl	D8726	FDA UDI	Class II	Active
Ethibond Excel	SXP02H	FDA UDI	Class II	Active
Prolene	EP8706H	FDA UDI	Class II	Active
Coated VICRYL	D8740	FDA UDI	Class II	Active
Ethibond Excel	X4843G	FDA UDI	Class II	Active
E-Pack	8570E	FDA UDI	Class II	Unknown
E-Pack	7293E	FDA UDI	Class II	Unknown
Coated VICRYL	J398H	FDA UDI	Class II	Active
Coated VICRYL	J311H	FDA UDI	Class II	Active
E-Pack	9601E	FDA UDI	Class II	Unknown
Monocryl	Y909G	FDA UDI	Class II	Active
Coated VICRYL	J694H	FDA UDI	Class II	Active
Ethilon	EH7822BH	FDA UDI	Class II	Active
Prolene	PK5696H	FDA UDI	Class II	Active
Coated VICRYL	J464G	FDA UDI	Class II	Active
E-Pack	9410E	FDA UDI	Class II	Unknown
E-Pack	8752E	FDA UDI	Class II	Unknown
Prolene	D8376	FDA UDI	Class II	Active
Coated VICRYL	D9358	FDA UDI	Class II	Active
Coated VICRYL	J814G	FDA UDI	Class II	Active
E-Pack	8175E	FDA UDI	Class II	Unknown
Ethilon	G661H	FDA UDI	Class II	Active
Prolene	D5081	FDA UDI	Class II	Active
Prolene	D8232	FDA UDI	Class II	Active
Coated VICRYL	D7857	FDA UDI	Class II	Active
Prolene	P8935	FDA UDI	Class II	Active
Coated VICRYL	J405G	FDA UDI	Class II	Active
Coated VICRYL	VCP347H	FDA UDI	Class II	Active
Ethicon	D9627	FDA UDI	Class II	Active
Ethibond Excel	CX45D	FDA UDI	Class II	Active
Coated VICRYL	VCP340H	FDA UDI	Class II	Unknown
Stratafix	SXPP1A305	FDA UDI	Class II	Active
Coated VICRYL	VCP751D	FDA UDI	Class II	Active

Related Companies

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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