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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 4 of 117

Device	Model / Reference	Registries	Class	Status
Ethicon	L103G	FDA UDI	Class II	Active
Coated VICRYL	J212H	FDA UDI	Class II	Active
Coated VICRYL	D8144	FDA UDI	Class II	Active
Ethicon	872H	FDA UDI	Class II	Active
E-Pack	8690E	FDA UDI	Class II	Unknown
Ethicon	TPW30	FDA UDI	Class II	Active
Monocryl	D9645	FDA UDI	Class II	Active
Ethicon	D9789	FDA UDI	Class II	Active
Gynecare Thermachoice	TC013	FDA UDI	Class III	Unknown
E-Pack	9504E	FDA UDI	Class II	Unknown
Prolene	8433H	FDA UDI	Class II	Active
Ethibond Excel	X926H	FDA UDI	Class II	Active
E-Pack	7438E	FDA UDI	Class II	Unknown
E-Pack	9804E	FDA UDI	Class II	Unknown
Prolene	8204H	FDA UDI	Class II	Active
E-Pack	8091E	FDA UDI	Class II	Unknown
Prolene	EPM8610	FDA UDI	Class II	Active
Coated VICRYL	VCP518H	FDA UDI	Class II	Active
Coated VICRYL	D6445	FDA UDI	Class II	Active
Pds	Z258H	FDA UDI	Class II	Active
Ethilon	D9635	FDA UDI	Class II	Active
Coated VICRYL	VCP500H	FDA UDI	Class II	Unknown
Pronova	3730LG	FDA UDI	Class II	Active
Pds	D6261	FDA UDI	Class II	Active
Ethilon	1611G	FDA UDI	Class II	Active
E-Pack	9973E	FDA UDI	Class II	Unknown
E-Pack	9607E	FDA UDI	Class II	Unknown
E-Pack	9433E	FDA UDI	Class II	Unknown
Monocryl	Y347H	FDA UDI	Class II	Active
E-Pack	7654E	FDA UDI	Class II	Unknown
Vicryl Rapide	VR935	FDA UDI	Class II	Active
Coated VICRYL	JJ31D	FDA UDI	Class II	Active
Ethicon	VSTL45	FDA UDI	Class II	Active
E-Pack	9965E	FDA UDI	Class II	Unknown
Ethilon	1674BH	FDA UDI	Class II	Active
Coated VICRYL	D9910	FDA UDI	Class II	Active
Ethilon	D3747	FDA UDI	Class II	Active
Ethicon	665H	FDA UDI	Class II	Active
Coated VICRYL	J00JG	FDA UDI	Class II	Unknown
Ethibond Excel	D8248	FDA UDI	Class II	Active
Pds	PDP352H	FDA UDI	Class II	Active
Ethicon	TPW50	FDA UDI	Class II	Unknown
Pronova	M3726	FDA UDI	Class II	Active
Pds	Z320H	FDA UDI	Class II	Active
Coated VICRYL	J522H	FDA UDI	Class II	Active
E-Pack	9127E	FDA UDI	Class II	Unknown
Coated VICRYL	J840D	FDA UDI	Class II	Active
Ethibond Excel	DC419	FDA UDI	Class II	Active
Pronova	D9744	FDA UDI	Class II	Active
Ethilon	9036G	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