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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 32 of 117

Device	Model / Reference	Registries	Class	Status
Prolene	D7477	FDA UDI	Class II	Active
Coated VICRYL	J284G	FDA UDI	Class II	Active
Ethibond Excel	D8572	FDA UDI	Class I	Active
Monocryl	Y946H	FDA UDI	Class II	Active
Pds	Z509G	FDA UDI	Class II	Active
Pds	Z311H	FDA UDI	Class II	Active
Coated VICRYL	JB944	FDA UDI	Class II	Active
Ethibond Excel	SXP82	FDA UDI	Class II	Active
E-Pack	6907E	FDA UDI	Class II	Unknown
Prolene	F2854H	FDA UDI	Class II	Active
Pds	D10057	FDA UDI	Class II	Active
Ethibond Excel	SX17H	FDA UDI	Class II	Active
Perma-Hand	D6563	FDA UDI	Class II	Active
Nurolon	D5685	FDA UDI	Class II	Active
Ethicon	D3000	FDA UDI	Class II	Active
Ethibond Excel	D8890	FDA UDI	Class II	Active
Mersilene	D9086	FDA UDI	Class II	Active
E-Pack	4241E	FDA UDI	Class II	Unknown
Prolene	D9720	FDA UDI	Class II	Active
Coated VICRYL	J494G	FDA UDI	Class II	Active
Pds	Z451H	FDA UDI	Class II	Active
E-Pack	8216E	FDA UDI	Class II	Unknown
Prolene	EH7476H	FDA UDI	Class II	Active
Prolene	8632H	FDA UDI	Class II	Active
Gynecare Interceed	4350XL	FDA UDI	Class III	Active
Ethibond	X719H	FDA UDI	Class II	Active
Ethilon	1994G	FDA UDI	Class II	Active
Ethilon	W738G	FDA UDI	Class II	Active
E-Pack	9044E	FDA UDI	Class II	Unknown
E-Pack	9355E	FDA UDI	Class II	Unknown
Perma-Hand	1780G	FDA UDI	Class II	Active
Ethicon	S104H	FDA UDI	Class II	Active
Stratafix	SXMP1B441	FDA UDI	Class II	Active
E-Pack	8735E	FDA UDI	Class II	Unknown
E-Pack	8255E	FDA UDI	Class II	Unknown
Stratafix	SXPP2B202	FDA UDI	Class II	Active
Prolene	D6820	FDA UDI	Class II	Active
Stratafix	SXPP1A406	FDA UDI	Class II	Active
Stratafix	SXMP2B419	FDA UDI	Class II	Active
E-Pack	9224E	FDA UDI	Class II	Unknown
Ethicon	853H	FDA UDI	Class II	Active
Coated VICRYL	VCP359H	FDA UDI	Class II	Active
E-Pack	8602E	FDA UDI	Class II	Unknown
Monocryl	Y740D	FDA UDI	Class II	Active
Ethibond Excel	X683G	FDA UDI	Class II	Active
Stratafix	SXPP1B424	FDA UDI	Class II	Active
Ethibond Excel	D9079	FDA UDI	Class II	Active
Coated VICRYL	J607H	FDA UDI	Class II	Active
Ethibond Excel	D9607	FDA UDI	Class II	Active
Prolene	EP8766H	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