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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 15 of 117

Device	Model / Reference	Registries	Class	Status
Ethibond Excel	D7576N	FDA UDI	Class II	Active
Stratafix	SXPP1A400	FDA UDI	Class II	Active
E-Pack	8725E	FDA UDI	Class II	Unknown
Coated VICRYL	VCPP80D	FDA UDI	Class II	Active
Prolene	C811G	FDA UDI	Class II	Active
Prolene	788G	FDA UDI	Class II	Active
Pds	ZB776D	FDA UDI	Class II	Active
Monocryl	Y908G	FDA UDI	Class II	Active
Coated VICRYL	VCP311H	FDA UDI	Class II	Unknown
Ethibond Excel	X4407H	FDA UDI	Class II	Active
Ethicon	884H	FDA UDI	Class II	Active
E-Pack	8041E	FDA UDI	Class II	Unknown
Ethicon	724G	FDA UDI	Class II	Active
E-Pack	7780E	FDA UDI	Class II	Unknown
Monocryl	Y464G	FDA UDI	Class II	Active
Coated VICRYL	J105T	FDA UDI	Class II	Active
E-Pack	9375E	FDA UDI	Class II	Unknown
E-Pack	8869E	FDA UDI	Class II	Unknown
Ethilon	1162H	FDA UDI	Class II	Active
Coated VICRYL	VCP494H	FDA UDI	Class II	Active
Ethibond Excel	D8922	FDA UDI	Class II	Active
Coated VICRYL	J813G	FDA UDI	Class II	Active
Stratafix	SXMP2B420	FDA UDI	Class II	Active
Coated VICRYL	VCP589H	FDA UDI	Class II	Unknown
Pds	ZB347	FDA UDI	Class II	Active
Coated VICRYL	J711T	FDA UDI	Class II	Active
Prolene	D9560	FDA UDI	Class II	Active
Mersilene	D7164	FDA UDI	Class II	Active
Ethilon	661H	FDA UDI	Class II	Active
Prolene	8935H	FDA UDI	Class II	Active
E-Pack	9934E	FDA UDI	Class II	Unknown
E-Pack	9280E	FDA UDI	Class II	Unknown
E-Pack	9136E	FDA UDI	Class II	Unknown
Pds	PDPB879G	FDA UDI	Class II	Active
E-Pack	8072E	FDA UDI	Class II	Unknown
Mersilene	D9176	FDA UDI	Class II	Active
Pronova	3709H	FDA UDI	Class II	Active
Perma-Hand	W775H	FDA UDI	Class II	Active
Prolene	D8911	FDA UDI	Class II	Active
Prolene	3DPL	FDA UDI	Class II	Active
Ethibond Excel	10X52	FDA UDI	Class II	Active
E-Pack	9505E	FDA UDI	Class II	Unknown
Ethilon	F2416H	FDA UDI	Class II	Active
Ethicon	773G	FDA UDI	Class II	Active
Prolene	8834H	FDA UDI	Class II	Active
Ethibond Excel	D6056	FDA UDI	Class II	Active
Ethicon	S103H	FDA UDI	Class II	Active
Prolene	D8352	FDA UDI	Class II	Active
Prolene	EP8703H	FDA UDI	Class II	Active
Coated VICRYL	VCP977H	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