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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 16 of 117

Device	Model / Reference	Registries	Class	Status
Coated VICRYL	VCP507G	FDA UDI	Class II	Active
Perma-Hand	10Q07	FDA UDI	Class II	Unknown
Prolene	D9614	FDA UDI	Class II	Active
Ethibond Excel	PX937H	FDA UDI	Class II	Active
Prolene	EP8752H	FDA UDI	Class II	Active
Ethibond Excel	D7810	FDA UDI	Class II	Active
Mersilene	D5556	FDA UDI	Class II	Active
E-Pack	8918E	FDA UDI	Class II	Unknown
E-Pack	8284E	FDA UDI	Class II	Unknown
Ethibond Excel	D9939	FDA UDI	Class II	Active
Coated VICRYL	D6810	FDA UDI	Class II	Active
Ethibond Excel	W4846	FDA UDI	Class II	Active
Perma-Hand	1675H	FDA UDI	Class II	Active
Ethicon	44T	FDA UDI	Class II	Active
Ethibond Excel	D9436	FDA UDI	Class II	Active
Ethicon	D8846	FDA UDI	Class II	Active
E-Pack	8804E	FDA UDI	Class II	Unknown
Ethibond Excel	CX21D	FDA UDI	Class II	Active
Prolene	D9071	FDA UDI	Class II	Active
E-Pack	7111E	FDA UDI	Class II	Unknown
Coated VICRYL	J682G	FDA UDI	Class II	Active
Ethicon Securestrap	OPSTRAP20	FDA UDI	Class II	Active
E-Pack	8644E	FDA UDI	Class II	Unknown
Prolene	D8050	FDA UDI	Class II	Active
Stratafix	SXPP2B433	FDA UDI	Class II	Active
Stratafix	SXMP2B410	FDA UDI	Class II	Active
Ethicon	925H	FDA UDI	Class II	Active
Ethilon	F3249BH	FDA UDI	Class II	Active
Coated VICRYL	JB340	FDA UDI	Class II	Active
Prolene	D8413	FDA UDI	Class II	Active
Ethicon	1643G	FDA UDI	Class II	Active
Pronova	3726H	FDA UDI	Class II	Active
Ethicon	1916G	FDA UDI	Class II	Unknown
Ethibond Excel	SX14H	FDA UDI	Class II	Unknown
Ethilon	D9577	FDA UDI	Class II	Active
Monocryl	Y4945H	FDA UDI	Class II	Active
Ethibond Excel	X937H	FDA UDI	Class II	Active
Pds	D10066	FDA UDI	Class II	Active
Prolene	M8768	FDA UDI	Class II	Active
Ethibond Excel	D9562	FDA UDI	Class II	Active
Ethibond Excel	D9306	FDA UDI	Class II	Active
Monocryl	D9568	FDA UDI	Class II	Active
E-Pack	5030E	FDA UDI	Class II	Unknown
Ethicon	D9033	FDA UDI	Class II	Active
Coated VICRYL	J260H	FDA UDI	Class II	Active
E-Pack	7431E	FDA UDI	Class II	Unknown
Ethicon	1621H	FDA UDI	Class II	Active
Ethilon	L880G	FDA UDI	Class II	Active
Ethilon	1673BH	FDA UDI	Class II	Active
Prolene	D7362	FDA UDI	Class II	Active

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