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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 36 of 117

Device	Model / Reference	Registries	Class	Status
Stratafix	SXMP1B438	FDA UDI	Class II	Active
Stratafix	SXMP1B117	FDA UDI	Class II	Active
E-Pack	9220E	FDA UDI	Class II	Unknown
E-Pack	9292E	FDA UDI	Class II	Unknown
Prolene	M8738	FDA UDI	Class II	Active
Ethibond Excel	D9010	FDA UDI	Class II	Active
Coated VICRYL	J553G	FDA UDI	Class II	Active
Ethibond Excel	D9459	FDA UDI	Class II	Active
Ethibond Excel	MPX27	FDA UDI	Class II	Active
Coated VICRYL	D8116	FDA UDI	Class II	Active
Coated VICRYL	VCP392H	FDA UDI	Class II	Unknown
Ethibond Excel	X964H	FDA UDI	Class II	Active
E-Pack	9623E	FDA UDI	Class II	Unknown
E-Pack	8073E	FDA UDI	Class II	Unknown
Perma-Hand	673H	FDA UDI	Class II	Active
Ethibond Excel	D9974N	FDA UDI	Class II	Active
Coated VICRYL	J421H	FDA UDI	Class II	Active
Ethilon	7770G	FDA UDI	Class II	Active
Coated VICRYL	J671G	FDA UDI	Class II	Active
Ethibond Excel	CX46D	FDA UDI	Class II	Active
Monocryl	Y922H	FDA UDI	Class II	Active
Perma-Hand	10Q06	FDA UDI	Class II	Unknown
Gynecare Gynemesh	GPSL	FDA UDI	Class II	Active
Monocryl	Y844G	FDA UDI	Class II	Active
Ethicon	U256H	FDA UDI	Class II	Active
E-Pack	8267E	FDA UDI	Class II	Unknown
E-Pack	7724E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP871H	FDA UDI	Class II	Active
Monocryl	YB4947H	FDA UDI	Class II	Active
E-Pack	3034E	FDA UDI	Class II	Unknown
Ethilon	1697H	FDA UDI	Class II	Active
E-Pack	8737E	FDA UDI	Class II	Unknown
Coated VICRYL	J4085G	FDA UDI	Class II	Active
Ethilon	EW526BH	FDA UDI	Class II	Active
Monocryl	Y214H	FDA UDI	Class II	Active
Ethilon	2820G	FDA UDI	Class II	Active
Perma-Hand	A186H	FDA UDI	Class II	Active
E-Pack	8305E	FDA UDI	Class II	Unknown
Ethibond Excel	D9249N	FDA UDI	Class II	Active
Prolene	D8292	FDA UDI	Class II	Active
Stratafix	SXPP1A431	FDA UDI	Class II	Active
Ethibond Excel	X717H	FDA UDI	Class II	Active
Prolene	PHSE	FDA UDI	Class II	Active
Ethi-Pak	DS32	FDA UDI	Class II	Active
Vicryl	D7498	FDA UDI	Class II	Active
Prolene	D6416	FDA UDI	Class II	Active
Ethilon	697G	FDA UDI	Class II	Active
Prolene	D10140	FDA UDI	Class II	Active
Prolene	EP8767LG	FDA UDI	Class II	Active
Ethibond Excel	D9830	FDA UDI	Class II	Active

Related Companies

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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