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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 37 of 117

Device	Model / Reference	Registries	Class	Status
Coated VICRYL	D8603	FDA UDI	Class II	Active
Coated VICRYL	D7984	FDA UDI	Class II	Active
Ethicon	904H	FDA UDI	Class II	Active
Prolene	D9207	FDA UDI	Class II	Active
E-Pack	9540E	FDA UDI	Class II	Unknown
Coated VICRYL	JB945H	FDA UDI	Class II	Active
Ethi-Pak	DS25	FDA UDI	Class II	Active
Ethicon Securestrap	STRAP12	FDA UDI	Class II	Active
Ethicon	1766G	FDA UDI	Class II	Active
Prolene	PB21H	FDA UDI	Class II	Active
Gynecare Versapoint	00463	FDA UDI	Class II	Unknown
E-Pack	8474E	FDA UDI	Class II	Unknown
Pds	Z420G	FDA UDI	Class II	Active
E-Pack	E7368	FDA UDI	Class II	Unknown
Coated VICRYL	VCPB977H	FDA UDI	Class II	Active
Coated VICRYL	J1909T	FDA UDI	Class II	Active
E-Pack	9502E	FDA UDI	Class II	Unknown
E-Pack	7830E	FDA UDI	Class II	Unknown
Pds	PDP338H	FDA UDI	Class II	Active
E-Pack	9498E	FDA UDI	Class II	Unknown
Ethilon	D6865	FDA UDI	Class II	Active
E-Pack	8974E	FDA UDI	Class II	Unknown
Ethicon	VSTL35	FDA UDI	Class II	Active
Coated VICRYL	VCP516H	FDA UDI	Class II	Unknown
Ethilon	F2415H	FDA UDI	Class II	Active
Coated VICRYL	D9314	FDA UDI	Class II	Active
Pds	D8298	FDA UDI	Class II	Active
Ethibond Excel	X304H	FDA UDI	Class II	Active
E-Pack	9533E	FDA UDI	Class II	Unknown
Ethibond Excel	10X52N	FDA UDI	Class II	Active
Vicryl	VKML	FDA UDI	Class II	Active
Coated VICRYL	VCP315H	FDA UDI	Class II	Unknown
Ethicon	L104G	FDA UDI	Class II	Active
Ethibond Excel	D9974	FDA UDI	Class II	Active
Stratafix	SXPP1A408	FDA UDI	Class II	Active
Monocryl	MCP416H	FDA UDI	Class II	Active
Stratafix	SXMP1B104	FDA UDI	Class II	Active
Prolene	D8373	FDA UDI	Class II	Active
E-Pack	9951E	FDA UDI	Class II	Unknown
Pds	PDP9261G	FDA UDI	Class II	Active
Pds	D9603	FDA UDI	Class II	Active
E-Pack	9312E	FDA UDI	Class II	Unknown
Pds	PDP9745H	FDA UDI	Class II	Active
Prolene	D7689	FDA UDI	Class II	Active
Coated VICRYL	J704T	FDA UDI	Class II	Active
Monocryl	D8655	FDA UDI	Class II	Active
Coated VICRYL	J587H	FDA UDI	Class II	Active
E-Pack	9173E	FDA UDI	Class II	Unknown
Prolene	D9935	FDA UDI	Class II	Active
Prolene	D5988	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