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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 8 of 117

Device	Model / Reference	Registries	Class	Status
Pds	ZB371	FDA UDI	Class II	Active
Ethibond Excel	D9311	FDA UDI	Class II	Active
Nurolon	C514D	FDA UDI	Class II	Active
Monocryl	Y943H	FDA UDI	Class II	Active
E-Pack	9186E	FDA UDI	Class II	Unknown
Prolene	D10090	FDA UDI	Class II	Active
Ethibond Excel	D8366	FDA UDI	Class II	Active
Coated VICRYL	D8001	FDA UDI	Class II	Active
E-Pack	9890E	FDA UDI	Class II	Unknown
Coated VICRYL	J455H	FDA UDI	Class II	Active
E-Pack	9019E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP947H	FDA UDI	Class II	Active
Ethicon	1792G	FDA UDI	Class II	Active
Ethicon	SG14T	FDA UDI	Class II	Active
Perma-Hand	D4655	FDA UDI	Class II	Active
Nurolon	D8965	FDA UDI	Class II	Active
Ethicon	D9148	FDA UDI	Class II	Active
Ethilon	9007G	FDA UDI	Class II	Active
E-Pack	7215E	FDA UDI	Class II	Unknown
Perma-Hand	583H	FDA UDI	Class II	Active
Ethibond Excel	X864H	FDA UDI	Class II	Active
Coated VICRYL	JB269	FDA UDI	Class II	Active
Coated VICRYL	D9957	FDA UDI	Class II	Active
Nurolon	D7473	FDA UDI	Class II	Active
E-Pack	4938E	FDA UDI	Class II	Unknown
E-Pack	6790E	FDA UDI	Class II	Unknown
Ethicon	U255H	FDA UDI	Class II	Active
Ethilon	F2415G	FDA UDI	Class II	Active
Coated VICRYL	VCPB41D	FDA UDI	Class II	Active
Ethicon	H820G	FDA UDI	Class II	Active
Prolene	EPM8704	FDA UDI	Class II	Active
Ethibond Excel	X519H	FDA UDI	Class II	Active
Monocryl	MCP922H	FDA UDI	Class II	Active
Coated VICRYL	J428H	FDA UDI	Class II	Active
Coated VICRYL	VCP583G	FDA UDI	Class II	Active
Coated VICRYL	VCP916H	FDA UDI	Class II	Active
Perma-Hand	M3T	FDA UDI	Class II	Active
Coated VICRYL	D9915	FDA UDI	Class II	Active
Coated VICRYL	J907G	FDA UDI	Class II	Active
Stratafix	SXPP1A445	FDA UDI	Class II	Active
Coated VICRYL	VCPB330H	FDA UDI	Class II	Active
E-Pack	9125E	FDA UDI	Class II	Unknown
Perma-Hand	707G	FDA UDI	Class II	Active
Coated VICRYL	D9003	FDA UDI	Class II	Active
Coated VICRYL	D6092	FDA UDI	Class II	Active
Perma-Hand	685H	FDA UDI	Class II	Active
Ethi-Pak	DS24	FDA UDI	Class II	Active
Pronova	PN3725H	FDA UDI	Class II	Active
Ethibond Excel	D10068	FDA UDI	Class II	Active
Coated VICRYL	D9914	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