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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 22 of 117

Device	Model / Reference	Registries	Class	Status
Pds	PDP6659H	FDA UDI	Class II	Active
Pds	D9798	FDA UDI	Class II	Active
Pronova	PN3717H	FDA UDI	Class II	Active
Ethicon	L115G	FDA UDI	Class II	Active
E-Pack	9076E	FDA UDI	Class II	Unknown
Perma-Hand	1984G	FDA UDI	Class II	Active
Prolene	D10143	FDA UDI	Class II	Active
Prolene	D9820	FDA UDI	Class II	Active
E-Pack	8505E	FDA UDI	Class II	Unknown
Pds	Z148H	FDA UDI	Class II	Active
Vicryl	V980G	FDA UDI	Class II	Active
Prolene	D9717	FDA UDI	Class II	Active
Prolene	8444H	FDA UDI	Class II	Active
E-Pack	9430E	FDA UDI	Class II	Unknown
Monocryl	YY30D	FDA UDI	Class II	Active
Pds	Z833G	FDA UDI	Class II	Active
Prolene	M8557	FDA UDI	Class II	Active
Ethicon	DW31B	FDA UDI	U	Active
E-Pack	9008E	FDA UDI	Class II	Unknown
Coated VICRYL	J532H	FDA UDI	Class II	Active
Prolene	D4295	FDA UDI	Class II	Active
Pds	D9395	FDA UDI	Class II	Active
E-Pack	9882E	FDA UDI	Class II	Unknown
Ethilon	1667G	FDA UDI	Class II	Active
Prolene	D8520	FDA UDI	Class II	Active
E-Pack	9819E	FDA UDI	Class II	Unknown
Pds	PDPB774D	FDA UDI	Class II	Active
Coated VICRYL	VCP714D	FDA UDI	Class II	Active
Ethilon	D9740	FDA UDI	Class II	Active
Coated VICRYL	J723D	FDA UDI	Class II	Active
E-Pack	7288E	FDA UDI	Class II	Unknown
Ethilon	D7811	FDA UDI	Class II	Active
Coated VICRYL	D5961	FDA UDI	Class II	Active
Coated VICRYL	VCP370H	FDA UDI	Class II	Active
Ethilon	D7785	FDA UDI	Class II	Active
Pds	Z416H	FDA UDI	Class II	Active
Ethicon	U213H	FDA UDI	Class II	Active
Ethicon	932H	FDA UDI	Class II	Active
Prolene	DC382	FDA UDI	Class II	Active
Prolene	3844G	FDA UDI	Class II	Active
Ethibond Excel	D7056	FDA UDI	Class II	Active
Ethibond Excel	X190G	FDA UDI	Class II	Active
Coated VICRYL	VCP608H	FDA UDI	Class II	Active
Prolene	EP8805H	FDA UDI	Class II	Active
Coated VICRYL	J588H	FDA UDI	Class II	Active
Mersilene	D8051	FDA UDI	Class II	Active
Pds	PDP789D	FDA UDI	Class II	Active
Ethibond Excel	X7733H	FDA UDI	Class II	Active
E-Pack	9077E	FDA UDI	Class II	Unknown
Pronova	3558H	FDA UDI	Class II	Active

Related Companies

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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