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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 28 of 117

Device	Model / Reference	Registries	Class	Status
Coated VICRYL	J474H	FDA UDI	Class II	Active
Prolene	8806H	FDA UDI	Class II	Active
Pronova	3710H	FDA UDI	Class II	Active
E-Pack	8813E	FDA UDI	Class II	Unknown
Mersilene	R750G	FDA UDI	Class II	Active
E-Pack	9262E	FDA UDI	Class II	Unknown
Pds	PDP359T	FDA UDI	Class II	Active
Stratafix	SXPP1B425	FDA UDI	Class II	Active
Ethicon	751G	FDA UDI	Class II	Active
Monocryl	MCP358H	FDA UDI	Class II	Active
E-Pack	5916E	FDA UDI	Class II	Unknown
Pds	D10040	FDA UDI	Class II	Active
E-Pack	5990E	FDA UDI	Class II	Unknown
Coated VICRYL	D6226	FDA UDI	Class II	Active
E-Pack	9513E	FDA UDI	Class II	Unknown
Monocryl	Y801D	FDA UDI	Class II	Active
Prolene	EP8807H	FDA UDI	Class II	Active
E-Pack	7416E	FDA UDI	Class II	Unknown
Prolene	8975H	FDA UDI	Class II	Active
E-Pack	8543E	FDA UDI	Class II	Unknown
E-Pack	8466E	FDA UDI	Class II	Unknown
Prolene	D8229	FDA UDI	Class II	Active
Prolene	D6731	FDA UDI	Class II	Active
Prolene	8617G	FDA UDI	Class II	Active
E-Pack	9409E	FDA UDI	Class II	Unknown
E-Pack	9118E	FDA UDI	Class II	Unknown
Coated VICRYL	J207G	FDA UDI	Class II	Active
Prolene	DC465	FDA UDI	Class II	Active
Ethilon	627H	FDA UDI	Class II	Active
Pds	Z451G	FDA UDI	Class II	Active
Pds	Z515G	FDA UDI	Class II	Active
Prolene	8634G	FDA UDI	Class II	Active
E-Pack	8688E	FDA UDI	Class II	Unknown
Monocryl	Y358H	FDA UDI	Class II	Active
E-Pack	9223E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP436H	FDA UDI	Class II	Active
Pronova	M3743	FDA UDI	Class II	Active
Ethibond Excel	DC406	FDA UDI	Class II	Active
Ethicon	D6562	FDA UDI	Class II	Active
Ethibond Excel	D5666	FDA UDI	Class II	Active
Ethibond Excel	PXX80N	FDA UDI	Class II	Active
E-Pack	9904E	FDA UDI	Class II	Unknown
Prolene	D5526	FDA UDI	Class II	Active
Coated VICRYL	VCP496H	FDA UDI	Class II	Active
Ethicon	G121H	FDA UDI	Class II	Active
Coated VICRYL	VCP699H	FDA UDI	Class II	Active
Coated VICRYL	VCP535H	FDA UDI	Class II	Active
Ethibond Excel	D9026	FDA UDI	Class II	Active
Ethibond Excel	D5757	FDA UDI	Class II	Active
E-Pack	7066E	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