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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 3 of 117

Device	Model / Reference	Registries	Class	Status
E-Pack	8849E	FDA UDI	Class II	Unknown
Ethibond Excel	D8083	FDA UDI	Class II	Active
Ethilon	699G	FDA UDI	Class II	Active
E-Pack	9051E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP645T	FDA UDI	Class II	Active
Coated VICRYL	J581G	FDA UDI	Class II	Active
Pronova	M3739	FDA UDI	Class II	Active
Prolene	D9425	FDA UDI	Class II	Active
E-Pack	5806E	FDA UDI	Class II	Unknown
E-Pack	8973E	FDA UDI	Class II	Unknown
Stratafix	SXPP2B419	FDA UDI	Class II	Active
Coated VICRYL	VCP359H	FDA UDI	Class II	Unknown
Ethicon	1627H	FDA UDI	Class II	Active
Ethibond Excel	SXP07H	FDA UDI	Class II	Active
Ethibond Excel	X32019H	FDA UDI	Class II	Active
Ethibond Excel	D6341N	FDA UDI	Class II	Active
Coated VICRYL	VCP334H	FDA UDI	Class II	Active
Prolene	D9364	FDA UDI	Class II	Active
Ethicon	1797G	FDA UDI	Class II	Active
Stratafix	SXPP1B115	FDA UDI	Class II	Active
Prolene	M8704	FDA UDI	Class II	Active
Ethilon	F2414H	FDA UDI	Class II	Active
Coated VICRYL	D10163	FDA UDI	Class II	Active
Perma-Hand	Q809H	FDA UDI	Class II	Unknown
Pds	ZB345H	FDA UDI	Class II	Active
Ethibond Excel	X934H	FDA UDI	Class II	Active
E-Pack	9818E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP268H	FDA UDI	Class II	Active
Coated VICRYL	VCP581G	FDA UDI	Class II	Unknown
Prolene	EP8740H	FDA UDI	Class II	Active
Pds	PDP339H	FDA UDI	Class II	Active
Coated VICRYL	J645H	FDA UDI	Class II	Active
E-Pack	8143E	FDA UDI	Class II	Unknown
E-Pack	9592E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP790D	FDA UDI	Class II	Active
Perma-Hand	LA53G	FDA UDI	Class II	Active
Coated VICRYL	VCP111G	FDA UDI	Class II	Active
Prolene	M8764	FDA UDI	Class II	Active
Ethibond Excel	D6584	FDA UDI	Class II	Active
Prolene	HS8556H	FDA UDI	Class II	Active
Nurolon	DC559	FDA UDI	Class II	Active
E-Pack	8510E	FDA UDI	Class II	Unknown
Monocryl	MCP213H	FDA UDI	Class II	Active
Ethilon	W1765	FDA UDI	Class II	Active
E-Pack	8497E	FDA UDI	Class II	Unknown
Perma-Hand	640G	FDA UDI	Class II	Active
Prolene	EPM8203	FDA UDI	Class II	Active
E-Pack	8830E	FDA UDI	Class II	Unknown
Ethicon	U246H	FDA UDI	Class II	Active
Ethibond Excel	D9238	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