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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 31 of 117

Device	Model / Reference	Registries	Class	Status
Coated VICRYL	J112T	FDA UDI	Class II	Active
Ethibond Excel	D8867	FDA UDI	Class II	Active
E-Pack	8894E	FDA UDI	Class II	Unknown
Ethibond Excel	MPX17	FDA UDI	Class II	Active
E-Pack	9567E	FDA UDI	Class II	Unknown
Pronova	PN3741LG	FDA UDI	Class II	Active
E-Pack	9462E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP519H	FDA UDI	Class II	Unknown
Monocryl	D8927	FDA UDI	Class II	Active
E-Pack	8691E	FDA UDI	Class II	Unknown
E-Pack	7147E	FDA UDI	Class II	Unknown
Ethibond Excel	D5286N	FDA UDI	Class II	Active
Stratafix	SXMP1B412	FDA UDI	Class II	Active
Stratafix	SXPP1A419	FDA UDI	Class II	Active
Ethicon	GL30G	FDA UDI	Class II	Active
Ethibond Excel	DC406N	FDA UDI	Class II	Active
E-Pack	9029E	FDA UDI	Class II	Unknown
Coated VICRYL	D7213	FDA UDI	Class II	Active
Coated VICRYL	J534H	FDA UDI	Class II	Active
Mersilene	D9416	FDA UDI	Class II	Active
E-Pack	7904E	FDA UDI	Class II	Unknown
E-Pack	9207E	FDA UDI	Class II	Unknown
Ethibond Excel	D9458	FDA UDI	Class II	Active
Prolene	8559H	FDA UDI	Class II	Active
Pds	D10049	FDA UDI	Class II	Active
E-Pack	8430E	FDA UDI	Class II	Unknown
Pds	Z968H	FDA UDI	Class II	Active
Prolene	PMSK	FDA UDI	Class II	Active
Coated VICRYL	VCPB945H	FDA UDI	Class II	Active
Coated VICRYL	VCP844G	FDA UDI	Class II	Active
Coated VICRYL	VCP392H	FDA UDI	Class II	Active
Coated VICRYL	VCP594G	FDA UDI	Class II	Active
Coated VICRYL	VCP463G	FDA UDI	Class II	Active
Coated VICRYL	VCP218H	FDA UDI	Class II	Active
Prolene	D9860	FDA UDI	Class II	Active
E-Pack	8522E	FDA UDI	Class II	Unknown
E-Pack	8361E	FDA UDI	Class II	Unknown
Ethilon	9005G	FDA UDI	Class II	Active
Gynecare Versapoint	01950	FDA UDI	Class II	Unknown
E-Pack	9816E	FDA UDI	Class II	Unknown
Monocryl	Y426H	FDA UDI	Class II	Active
Coated VICRYL	VCP787D	FDA UDI	Class II	Active
Pds	PDP503G	FDA UDI	Class II	Active
Monocryl	MCP823G	FDA UDI	Class II	Active
Stratafix	SXPP1A446	FDA UDI	Class II	Active
Nurolon	C554D	FDA UDI	Class II	Active
Perma-Hand	K833H	FDA UDI	Class II	Active
Pds	Z924H	FDA UDI	Class II	Active
E-Pack	9718E	FDA UDI	Class II	Unknown
Monocryl	MCPB316H	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