Is this your brand? Sign in to claim ownership.

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 27 of 117

Device	Model / Reference	Registries	Class	Status
Coated VICRYL	VCP459H	FDA UDI	Class II	Unknown
Stratafix	SXPP1B203	FDA UDI	Class II	Active
Ethicon	1744G	FDA UDI	Class II	Active
E-Pack	8554E	FDA UDI	Class II	Unknown
Ethibond Excel	D8725	FDA UDI	Class II	Active
Pds	D10169	FDA UDI	Class II	Active
Prolene	D8506	FDA UDI	Class II	Active
E-Pack	9604E	FDA UDI	Class II	Unknown
Pds	PDP695H	FDA UDI	Class II	Active
Ethibond Excel	PXX77N	FDA UDI	Class II	Active
Ethibond Excel	D9079N	FDA UDI	Class II	Active
Stratafix	SXPP1A409	FDA UDI	Class II	Active
Coated VICRYL	VCP511G	FDA UDI	Class II	Active
Coated VICRYL	J327H	FDA UDI	Class II	Active
E-Pack	8615E	FDA UDI	Class II	Unknown
E-Pack	7474E	FDA UDI	Class II	Unknown
E-Pack	7160E	FDA UDI	Class II	Unknown
Ethicon	638G	FDA UDI	Class II	Active
E-Pack	9561E	FDA UDI	Class II	Unknown
E-Pack	7634E	FDA UDI	Class II	Unknown
Pds	ZB346H	FDA UDI	Class II	Active
Prolene	EPM8723	FDA UDI	Class II	Active
Ethibond Excel	D7925	FDA UDI	Class II	Active
Coated VICRYL	VCP423H	FDA UDI	Class II	Active
Coated VICRYL	J590G	FDA UDI	Class II	Active
Coated VICRYL	J502H	FDA UDI	Class II	Active
E-Pack	7857E	FDA UDI	Class II	Unknown
Prolene	D10116	FDA UDI	Class II	Active
Perma-Hand	C013D	FDA UDI	Class II	Active
Coated VICRYL	J789D	FDA UDI	Class II	Active
Gynecare Versapoint	01936	FDA UDI	Class II	Unknown
Monocryl	D9418	FDA UDI	Class II	Active
Prolene	8606G	FDA UDI	Class II	Active
E-Pack	9124E	FDA UDI	Class II	Unknown
E-Pack	8772E	FDA UDI	Class II	Unknown
E-Pack	9803E	FDA UDI	Class II	Unknown
Prolene	W8597	FDA UDI	Class II	Active
Perma-Hand	D9747	FDA UDI	Class II	Active
Prolene	D7717	FDA UDI	Class II	Active
Coated VICRYL	D7294	FDA UDI	Class II	Active
Ethicon	742G	FDA UDI	Class II	Active
Ethilon	626H	FDA UDI	Class II	Active
Prolene	D9996	FDA UDI	Class II	Active
Ethicon	G122H	FDA UDI	Class II	Active
E-Pack	9489E	FDA UDI	Class II	Unknown
E-Pack	9251E	FDA UDI	Class II	Unknown
Coated VICRYL	J911T	FDA UDI	Class II	Active
Ethicon	817H	FDA UDI	Class II	Active
Ethicon	D8405	FDA UDI	Class II	Active
Ethicon	801H	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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