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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 18 of 117

Device	Model / Reference	Registries	Class	Status
Ethilon	7717G	FDA UDI	Class II	Active
Coated VICRYL	VCP453G	FDA UDI	Class II	Active
Coated VICRYL	VCP260H	FDA UDI	Class II	Active
Perma-Hand	D8085	FDA UDI	Class II	Active
Perma-Hand	D2484	FDA UDI	Class II	Active
Ethicon	1791G	FDA UDI	Class II	Active
Pds	Z114H	FDA UDI	Class II	Active
Ethicon	814H	FDA UDI	Class II	Active
Ethilon	2894G	FDA UDI	Class II	Active
Coated VICRYL	D10111	FDA UDI	Class II	Active
Ethilon	W1756	FDA UDI	Class II	Active
Mersilene	D6094	FDA UDI	Class II	Active
Ethibond Excel	CX41D	FDA UDI	Class II	Active
E-Pack	6400E	FDA UDI	Class II	Unknown
E-Pack	9706E	FDA UDI	Class II	Unknown
Stratafix	SXMP1B411	FDA UDI	Class II	Active
Pronova	PNM3709	FDA UDI	Class II	Active
Pronova	PN3710H	FDA UDI	Class II	Active
Coated VICRYL	VCP428H	FDA UDI	Class II	Active
Prolene	M8741	FDA UDI	Class II	Active
Nurolon	D6478	FDA UDI	Class II	Active
E-Pack	9279E	FDA UDI	Class II	Unknown
Stratafix	SXPP1B406	FDA UDI	Class II	Active
Prolene	W8712	FDA UDI	Class II	Active
Pds	Z442H	FDA UDI	Class II	Active
Ethibond Excel	X7497H	FDA UDI	Class II	Active
Monocryl	Y356H	FDA UDI	Class II	Active
Prolene	P8522H	FDA UDI	Class II	Active
Pronova	M3753	FDA UDI	Class II	Active
Prolene	D10172	FDA UDI	Class II	Active
Mersilene	D7278	FDA UDI	Class II	Active
E-Pack	7031E	FDA UDI	Class II	Unknown
Coated VICRYL	J959H	FDA UDI	Class II	Active
E-Pack	E7366	FDA UDI	Class II	Unknown
Pronova	3701H	FDA UDI	Class II	Active
Ethilon	2881G	FDA UDI	Class II	Active
E-Pack	7927E	FDA UDI	Class II	Unknown
E-Pack	8801E	FDA UDI	Class II	Unknown
Prolene	M8717	FDA UDI	Class II	Active
E-Pack	7230E	FDA UDI	Class II	Unknown
Coated VICRYL	J517H	FDA UDI	Class II	Active
Prolene	D9066	FDA UDI	Class II	Active
Ethibond Excel	D5834	FDA UDI	Class II	Active
Prolene	EH7222H	FDA UDI	Class II	Active
Coated VICRYL	J944H	FDA UDI	Class II	Active
Coated VICRYL	VCP944H	FDA UDI	Class II	Active
E-Pack	7907E	FDA UDI	Class II	Unknown
Monocryl	D9473	FDA UDI	Class II	Active
Ethibond Excel	D9191	FDA UDI	Class II	Active
Prolene	F1861H	FDA UDI	Class II	Active

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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