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 12 of 117

Device	Model / Reference	Registries	Class	Status
E-Pack	6799E	FDA UDI	Class II	Unknown
Nurolon	5665G	FDA UDI	Class II	Active
Prolene	D7879	FDA UDI	Class II	Active
Monocryl	MCPB945H	FDA UDI	Class II	Active
Pds	Z9077H	FDA UDI	Class II	Active
Ethibond Excel	D10099	FDA UDI	Class II	Active
E-Pack	7226E	FDA UDI	Class II	Unknown
Coated VICRYL	D9156	FDA UDI	Class II	Unknown
E-Pack	7756E	FDA UDI	Class II	Unknown
Gynecare Thermachoice	00825	FDA UDI	Class III	Unknown
E-Pack	8122E	FDA UDI	Class II	Unknown
Nurolon	C521D	FDA UDI	Class II	Active
Prolene	D9524	FDA UDI	Class II	Active
Ethibond Excel	D9254	FDA UDI	Class II	Active
E-Pack	9027E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP761D	FDA UDI	Class II	Active
Ethicon	G182H	FDA UDI	Class II	Active
Monocryl	MCP415H	FDA UDI	Class II	Active
Prolene	D9945	FDA UDI	Class II	Active
Ethibond Excel	PXX82	FDA UDI	Class II	Active
E-Pack	9824E	FDA UDI	Class II	Unknown
Pds	PDPB765D	FDA UDI	Class II	Active
E-Pack	9525E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP569H	FDA UDI	Class II	Active
Ethibond Excel	MB66G	FDA UDI	Class II	Active
E-Pack	7728E	FDA UDI	Class II	Unknown
Prolene	D9899	FDA UDI	Class II	Active
E-Pack	7285E	FDA UDI	Class II	Unknown
E-Pack	6415E	FDA UDI	Class II	Unknown
Prolene	D9795	FDA UDI	Class II	Active
Coated VICRYL	J979H	FDA UDI	Class II	Active
Coated VICRYL	J195H	FDA UDI	Class II	Active
Ethilon	663G	FDA UDI	Class II	Active
Prolene	D9264	FDA UDI	Class II	Active
Monocryl	Y4213H	FDA UDI	Class II	Active
Ethicon	S105H	FDA UDI	Class II	Active
Ethibond Excel	D8416	FDA UDI	Class II	Active
E-Pack	7807E	FDA UDI	Class II	Unknown
Ethibond Excel	EH7713LG	FDA UDI	Class II	Active
E-Pack	8013E	FDA UDI	Class II	Unknown
E-Pack	7775E	FDA UDI	Class II	Unknown
E-Pack	9510E	FDA UDI	Class II	Unknown
Coated VICRYL	VCPPB31D	FDA UDI	Class II	Active
Monocryl	MCP493G	FDA UDI	Class II	Active
Ethibond Excel	X423H	FDA UDI	Class II	Active
Pds	PDP463G	FDA UDI	Class II	Active
Pds	D7882	FDA UDI	Class II	Active
Ethi-Pak	DS26	FDA UDI	Class II	Active
E-Pack	9290E	FDA UDI	Class II	Unknown
Ethibond Excel	D5519	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