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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 23 of 117

Device	Model / Reference	Registries	Class	Status
Pds	PDP801D	FDA UDI	Class II	Active
Monocryl	MCP835G	FDA UDI	Class II	Active
E-Pack	7690E	FDA UDI	Class II	Unknown
E-Pack	8841E	FDA UDI	Class II	Unknown
Prolene	8755H	FDA UDI	Class II	Active
Ethilon	1965G	FDA UDI	Class II	Active
Pds	Z879G	FDA UDI	Class II	Active
Ethibond Excel	X7056H	FDA UDI	Class II	Active
Ethibond Excel	D8705	FDA UDI	Class II	Active
Stratafix	SXPP1B415	FDA UDI	Class II	Active
Mersilene	R770G	FDA UDI	Class II	Active
Prolene	8636H	FDA UDI	Class II	Active
Prolene	D6141	FDA UDI	Class II	Active
Pds	D10132	FDA UDI	Class II	Active
Ethicon	3802T	FDA UDI	Class II	Unknown
E-Pack	7616E	FDA UDI	Class II	Unknown
Ethilon	W786BG	FDA UDI	Class II	Active
Pds	D6361	FDA UDI	Class II	Active
Coated VICRYL	VCPB724D	FDA UDI	Class II	Active
Ethibond Excel	D8868	FDA UDI	Class II	Active
E-Pack	8239E	FDA UDI	Class II	Unknown
Ethibond Excel	X925H	FDA UDI	Class II	Active
Ethicon	3013SP	FDA UDI	Class III	Active
Stratafix	SXMP1B102	FDA UDI	Class II	Active
Stratafix	SXPP1A201	FDA UDI	Class II	Active
Ethibond Excel	X550H	FDA UDI	Class II	Active
Monocryl	Y492G	FDA UDI	Class II	Active
Ethibond Excel	PXX52N	FDA UDI	Class II	Active
Nurolon	D7309	FDA UDI	Class II	Active
Ethilon	F2422H	FDA UDI	Class II	Active
Stratafix	SXPP1A440	FDA UDI	Class II	Active
E-Pack	9472E	FDA UDI	Class II	Unknown
E-Pack	8344E	FDA UDI	Class II	Unknown
Coated VICRYL	J259H	FDA UDI	Class II	Active
Ethibond Excel	D7390	FDA UDI	Class II	Active
Coated VICRYL	VCP771D	FDA UDI	Class II	Active
Monocryl	MCP490G	FDA UDI	Class II	Active
Prolene	M8305	FDA UDI	Class II	Active
E-Pack	8924E	FDA UDI	Class II	Unknown
E-Pack	8526E	FDA UDI	Class II	Unknown
Ethicon	864H	FDA UDI	Class II	Active
Coated VICRYL	VCP917H	FDA UDI	Class II	Active
Ethilon	U7000	FDA UDI	Class II	Active
Ethicon	4923H	FDA UDI	Class II	Active
Coated VICRYL	J496H	FDA UDI	Class II	Active
Mersilene	D3860	FDA UDI	Class II	Active
Ethibond Excel	MX69G	FDA UDI	Class II	Active
Prolene	D6781	FDA UDI	Class II	Active
PDS Plates	ZFP8	FDA UDI	Class II	Active
Coated VICRYL	VCP107G	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Importers

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Notified Bodies

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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