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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 7 of 117

Device	Model / Reference	Registries	Class	Status
Prolene	D10139	FDA UDI	Class II	Active
Prolene	EPH8890H	FDA UDI	Class II	Active
Ethibond Excel	D8492	FDA UDI	Class II	Active
Pds	Z441H	FDA UDI	Class II	Active
E-Pack	9131E	FDA UDI	Class II	Unknown
Ethibond Excel	D9070	FDA UDI	Class II	Active
Prolene	W982G	FDA UDI	Class II	Active
E-Pack	8874E	FDA UDI	Class II	Unknown
Ethibond Excel	E6194G	FDA UDI	Class II	Active
Ethicon	S102H	FDA UDI	Class II	Active
E-Pack	9509E	FDA UDI	Class II	Unknown
Mersilene	EH7164H	FDA UDI	Class II	Active
Perma-Hand	K570H	FDA UDI	Class II	Active
Coated VICRYL	J460H	FDA UDI	Class II	Active
Prolene	M8732	FDA UDI	Class II	Active
Ethicon	3921S	FDA UDI	Class II	Unknown
Ethilon	W1769	FDA UDI	Class II	Active
Ethicon	D9187	FDA UDI	Class II	Active
E-Pack	9145E	FDA UDI	Class II	Unknown
Pds	D6713	FDA UDI	Class II	Active
Ethibond Excel	D7809	FDA UDI	Class II	Active
Coated VICRYL	J771D	FDA UDI	Class II	Active
Ethibond Excel	DC472	FDA UDI	Class II	Active
Prolene	D6619	FDA UDI	Class II	Active
Pds	PDP137H	FDA UDI	Class II	Active
Stratafix	SXPP1B419	FDA UDI	Class II	Active
Pds	PDP259H	FDA UDI	Class II	Active
E-Pack	9871E	FDA UDI	Class II	Unknown
Ethibond Excel	10X72	FDA UDI	Class II	Active
Prolene	1710G	FDA UDI	Class II	Active
E-Pack	9026E	FDA UDI	Class II	Unknown
Ethicon	D9793	FDA UDI	Class II	Active
Coated VICRYL	D6863	FDA UDI	Class II	Active
Prolene	D7530	FDA UDI	Class II	Active
Prolene	EP8741H	FDA UDI	Class II	Active
Vicryl Rapide	VR1695	FDA UDI	Class II	Active
Prolene	F1840H	FDA UDI	Class II	Active
Prolene	D10031	FDA UDI	Class II	Active
E-Pack	8599E	FDA UDI	Class II	Unknown
Pds	Z690G	FDA UDI	Class II	Active
Stratafix	SXMP1B434	FDA UDI	Class II	Active
Ethilon	749G	FDA UDI	Class II	Active
Prolene	D8185	FDA UDI	Class II	Active
Prolene	EPH8720H	FDA UDI	Class II	Active
Prolene	EP8754H	FDA UDI	Class II	Active
Coated VICRYL	J208G	FDA UDI	Class II	Active
Coated VICRYL	J764D	FDA UDI	Class II	Active
E-Pack	8591E	FDA UDI	Class II	Unknown
E-Pack	4941E	FDA UDI	Class II	Unknown
Ethicon	1632G	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