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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 34 of 117

Device	Model / Reference	Registries	Class	Status
E-Pack	9263E	FDA UDI	Class II	Unknown
Perma-Hand	C026D	FDA UDI	Class II	Active
Pds	PDP468H	FDA UDI	Class II	Active
E-Pack	9459E	FDA UDI	Class II	Unknown
Monocryl	Y463G	FDA UDI	Class II	Active
Pds	PDP370T	FDA UDI	Class II	Active
Ethicon Securestrap	STRAP25	FDA UDI	Class II	Active
Ethibond Excel	X870H	FDA UDI	Class II	Active
Pds	D8251	FDA UDI	Class II	Active
Ethibond Excel	X551H	FDA UDI	Class II	Active
Ethibond Excel	X556H	FDA UDI	Class II	Active
E-Pack	9681E	FDA UDI	Class II	Unknown
Pds	PDP879G	FDA UDI	Class II	Active
Coated VICRYL	J328H	FDA UDI	Class II	Active
SURGICEL SNoW	2081	FDA UDI	Class III	Active
E-Pack	9614E	FDA UDI	Class II	Unknown
E-Pack	9802E	FDA UDI	Class II	Unknown
Prolene	EP8747H	FDA UDI	Class II	Active
Ethicon	G126H	FDA UDI	Class II	Active
Prolene	F2847H	FDA UDI	Class II	Active
Prolene	HS6856H	FDA UDI	Class II	Active
Ethibond Excel	D7805	FDA UDI	Class II	Active
Pds	Z844G	FDA UDI	Class II	Active
Nurolon	C572D	FDA UDI	Class II	Active
Coated VICRYL	J713D	FDA UDI	Class II	Active
Coated VICRYL	J500H	FDA UDI	Class II	Active
Ethibond Excel	SXP02	FDA UDI	Class II	Active
Ethibond Excel	DC425	FDA UDI	Class II	Active
Ethilon	664H	FDA UDI	Class II	Active
Gynecare Versapoint	01938	FDA UDI	Class II	Unknown
Coated VICRYL	D9147	FDA UDI	Class II	Active
Monocryl	D8815	FDA UDI	Class II	Active
E-Pack	9304E	FDA UDI	Class II	Unknown
Ethilon	698G	FDA UDI	Class II	Active
E-Pack	9827E	FDA UDI	Class II	Unknown
Coated VICRYL	J267H	FDA UDI	Class II	Active
Coated VICRYL	J315H	FDA UDI	Class II	Active
Ethibond Excel	D8309	FDA UDI	Class II	Active
Coated VICRYL	VCP936H	FDA UDI	Class II	Active
E-Pack	9144E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP740D	FDA UDI	Class II	Active
Prolene	8665G	FDA UDI	Class II	Active
Ethibond Excel	D5862	FDA UDI	Class II	Active
Prolene	D9995	FDA UDI	Class II	Active
Nurolon	C563D	FDA UDI	Class II	Active
Prolene	8697G	FDA UDI	Class II	Active
Coated VICRYL	J706T	FDA UDI	Class II	Active
E-Pack	8645E	FDA UDI	Class II	Unknown
E-Pack	7375E	FDA UDI	Class II	Unknown
Prolene	SPM3XL	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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