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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 21 of 117

Device	Model / Reference	Registries	Class	Status
Prolene	M8753	FDA UDI	Class II	Active
Prolene	8357H	FDA UDI	Class II	Active
Ethicon	811H	FDA UDI	Class II	Active
Prolene	EPM8738	FDA UDI	Class II	Active
Coated VICRYL	VCP270H	FDA UDI	Class II	Unknown
Ethibond Excel	X916H	FDA UDI	Class II	Active
Prolene	EP8735H	FDA UDI	Class II	Active
Pronova	3304H	FDA UDI	Class II	Active
Coated VICRYL	D8739	FDA UDI	Class II	Active
E-Pack	9189E	FDA UDI	Class II	Unknown
Prolene	8412H	FDA UDI	Class II	Active
Mersilene	D5574	FDA UDI	Class II	Active
E-Pack	8525E	FDA UDI	Class II	Unknown
Pds	PDP466H	FDA UDI	Class II	Active
Nurolon	D6950	FDA UDI	Class II	Active
Ethilon	1740G	FDA UDI	Class II	Active
E-Pack	8826E	FDA UDI	Class II	Unknown
Ethilon	D8626	FDA UDI	Class II	Active
Tabotamp Fibrillar	431963	FDA UDI	Class III	Unknown
Coated VICRYL	VCP593G	FDA UDI	Class II	Active
Coated VICRYL	J504G	FDA UDI	Class II	Active
Prolene	EP8767H	FDA UDI	Class II	Active
Coated VICRYL	D8349	FDA UDI	Class II	Active
E-Pack	9061E	FDA UDI	Class II	Unknown
Ethicon	D8160	FDA UDI	Class II	Active
Prolene	8696G	FDA UDI	Class II	Active
Prolene	OSM8743	FDA UDI	Class II	Active
Ethibond Excel	W883	FDA UDI	Class II	Active
Pds	PDP422H	FDA UDI	Class II	Active
Coated VICRYL	J369H	FDA UDI	Class II	Active
Ethibond Excel	X444H	FDA UDI	Class II	Active
Prolene	8953H	FDA UDI	Class II	Active
Perma-Hand	K882H	FDA UDI	Class II	Active
Coated VICRYL	VCP504G	FDA UDI	Class II	Active
E-Pack	9562E	FDA UDI	Class II	Unknown
Prolene	OSM8742	FDA UDI	Class II	Active
Prolene	EP8800H	FDA UDI	Class II	Active
Pds	Z357H	FDA UDI	Class II	Active
Ethibond Excel	D8107	FDA UDI	Class II	Active
E-Pack	8600E	FDA UDI	Class II	Unknown
E-Pack	8450E	FDA UDI	Class II	Unknown
E-Pack	9840E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP587H	FDA UDI	Class II	Active
Coated VICRYL	VCP618H	FDA UDI	Class II	Active
Coated VICRYL	J496G	FDA UDI	Class II	Active
Vicryl	D7329	FDA UDI	Class II	Active
E-Pack	9473E	FDA UDI	Class II	Unknown
Prolene	8681H	FDA UDI	Class II	Active
E-Pack	8678E	FDA UDI	Class II	Unknown
Prolene	EP8726H	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