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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 25 of 117

Device	Model / Reference	Registries	Class	Status
Gynecare Versapoint	01931	FDA UDI	Class II	Unknown
Ethilon	EH7793BH	FDA UDI	Class II	Active
Pds	PDP823G	FDA UDI	Class II	Active
Coated VICRYL	VCP284G	FDA UDI	Class II	Active
Coated VICRYL	D9686	FDA UDI	Class II	Active
E-Pack	9812E	FDA UDI	Class II	Unknown
E-Pack	9383E	FDA UDI	Class II	Unknown
E-Pack	9344E	FDA UDI	Class II	Unknown
Ethilon	1691H	FDA UDI	Class II	Active
Prolene	EH7920H	FDA UDI	Class II	Active
Pds	PDP507G	FDA UDI	Class II	Active
Ethicon	1652G	FDA UDI	Class II	Active
Pds	PDPB370T	FDA UDI	Class II	Active
Ethibond Excel	D9070N	FDA UDI	Class II	Active
Prolene	M8765	FDA UDI	Class II	Active
Ethibond Excel	D8573	FDA UDI	Class I	Active
Prolene	EPM8735	FDA UDI	Class II	Active
E-Pack	6603E	FDA UDI	Class II	Unknown
E-Pack	9426E	FDA UDI	Class II	Unknown
Coated VICRYL	J306H	FDA UDI	Class II	Active
Ethibond Excel	X513H	FDA UDI	Class II	Active
Ethibond	X889H	FDA UDI	Class II	Active
Prolene	D7946	FDA UDI	Class II	Active
Ethicon	D4635	FDA UDI	Class II	Active
Ethibond Excel	D8724	FDA UDI	Class II	Active
E-Pack	9875E	FDA UDI	Class II	Unknown
E-Pack	9557E	FDA UDI	Class II	Unknown
Monocryl	Y823G	FDA UDI	Class II	Active
Coated VICRYL	VCP841D	FDA UDI	Class II	Active
Coated VICRYL	J110T	FDA UDI	Class II	Active
Coated VICRYL	VCP480H	FDA UDI	Class II	Active
Pds	PDP420G	FDA UDI	Class II	Active
Prolene	M8203	FDA UDI	Class II	Active
Ethibond Excel	D6048	FDA UDI	Class II	Active
E-Pack	9358E	FDA UDI	Class II	Unknown
Coated VICRYL	J381H	FDA UDI	Class II	Active
Ethilon	D10186	FDA UDI	Class II	Active
Pds	D8418	FDA UDI	Class II	Active
Ethicon	L111G	FDA UDI	Class II	Active
Ethibond Excel	D9975	FDA UDI	Class II	Active
Prolene	D9068	FDA UDI	Class II	Active
E-Pack	9057E	FDA UDI	Class II	Unknown
Ethicon	TPW52	FDA UDI	Class II	Unknown
Coated VICRYL	D7212	FDA UDI	Class II	Active
Prolene	W8664	FDA UDI	Class II	Active
Pds	PDP7532G	FDA UDI	Class II	Active
Pds	Z347H	FDA UDI	Class II	Active
Prolene	DC631	FDA UDI	Class II	Active
Perma-Hand	7729G	FDA UDI	Class II	Active
E-Pack	8984E	FDA UDI	Class II	Unknown

Related Companies

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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