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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 10 of 117

Device	Model / Reference	Registries	Class	Status
Vicryl	VCP5749T	FDA UDI	Class II	Active
Coated VICRYL	VCP784D	FDA UDI	Class II	Active
Coated VICRYL	VCPB357H	FDA UDI	Class II	Active
Ethibond Excel	D10167	FDA UDI	Class II	Active
Monocryl	D8893	FDA UDI	Class II	Active
Ethibond Excel	D6165	FDA UDI	Class II	Active
E-Pack	8500E	FDA UDI	Class II	Unknown
Prolene	M8711	FDA UDI	Class II	Active
Pronova	PNM3805	FDA UDI	Class II	Active
Ethibond Excel	X761H	FDA UDI	Class II	Active
Mersilene	1762G	FDA UDI	Class II	Active
Coated VICRYL	VCPB864D	FDA UDI	Class II	Active
Pds	PDP877G	FDA UDI	Class II	Active
Prolene	EH7255H	FDA UDI	Class II	Active
Monocryl	D7611	FDA UDI	Class II	Active
Coated VICRYL	J340H	FDA UDI	Class II	Active
E-Pack	9228E	FDA UDI	Class II	Unknown
Ethilon	1945G	FDA UDI	Class II	Unknown
Prolene	2793G	FDA UDI	Class II	Active
Ethicon	796G	FDA UDI	Class II	Active
Perma-Hand	D8600	FDA UDI	Class II	Active
Prolene	D9511	FDA UDI	Class II	Active
Coated VICRYL	J493G	FDA UDI	Class II	Active
E-Pack	9583E	FDA UDI	Class II	Unknown
Pronova	PN3806H	FDA UDI	Class II	Active
Coated VICRYL	VCP940H	FDA UDI	Class II	Active
Nurolon	D4265	FDA UDI	Class II	Active
E-Pack	9202E	FDA UDI	Class II	Unknown
Pds	D8978	FDA UDI	Class II	Active
Prolene	8725H	FDA UDI	Class II	Active
Ethicon	839H	FDA UDI	Class II	Active
Perma-Hand	1679H	FDA UDI	Class II	Active
E-Pack	6166E	FDA UDI	Class II	Unknown
Coated VICRYL	D9708	FDA UDI	Class II	Active
Monocryl	Y732H	FDA UDI	Class II	Active
Coated VICRYL	JJ80D	FDA UDI	Class II	Active
Prolene	EH7568H	FDA UDI	Class II	Active
Monocryl	Y835G	FDA UDI	Class II	Active
Coated VICRYL	VCP310H	FDA UDI	Class II	Unknown
Ethibond Excel	X807H	FDA UDI	Class II	Active
Ethibond Excel	D8741	FDA UDI	Class II	Active
Prolene	W534G	FDA UDI	Class II	Active
Coated VICRYL	VCP357H	FDA UDI	Class II	Active
Coated VICRYL	J773D	FDA UDI	Class II	Active
Ethibond Excel	DC650	FDA UDI	Class II	Active
Coated VICRYL	D9792	FDA UDI	Class II	Active
Monocryl	MCP942G	FDA UDI	Class II	Active
Monocryl	Y814G	FDA UDI	Class II	Active
E-Pack	8318E	FDA UDI	Class II	Unknown
E-Pack	4331E	FDA UDI	Class II	Unknown

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