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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 29 of 117

Device	Model / Reference	Registries	Class	Status
Coated VICRYL	J602H	FDA UDI	Class II	Active
Prolene	D8688	FDA UDI	Class II	Active
Ethibond Excel	D8515	FDA UDI	Class II	Active
Coated VICRYL	VCP214H	FDA UDI	Class II	Active
E-Pack	4490E	FDA UDI	Class II	Unknown
Stratafix	SXMP1B440	FDA UDI	Class II	Active
Pds	Z423H	FDA UDI	Class II	Active
Pds	PDP317H	FDA UDI	Class II	Active
E-Pack	8755E	FDA UDI	Class II	Unknown
Pds	PDP583G	FDA UDI	Class II	Active
E-Pack	7583E	FDA UDI	Class II	Unknown
Stratafix	SXMP1B118	FDA UDI	Class II	Active
Ethicon	923H	FDA UDI	Class II	Active
Coated VICRYL	J575G	FDA UDI	Class II	Active
Dermabond Advanced	DNX12	FDA UDI	Class II	Active
Perma-Hand	C021D	FDA UDI	Class II	Active
Prolene	EP8718H	FDA UDI	Class II	Active
Prolene	M8739	FDA UDI	Class II	Active
Nurolon	D4503	FDA UDI	Class II	Active
Perma-Hand	A307H	FDA UDI	Class II	Active
Vicryl	J783D	FDA UDI	Class II	Active
E-Pack	5287E	FDA UDI	Class II	Unknown
E-Pack	9371E	FDA UDI	Class II	Unknown
Pds	PDP443H	FDA UDI	Class II	Active
Perma-Hand	D7877	FDA UDI	Class II	Active
Stratafix	SXPP1B102	FDA UDI	Class II	Active
E-Pack	8668E	FDA UDI	Class II	Unknown
E-Pack	9828E	FDA UDI	Class II	Unknown
Prolene	PB30H	FDA UDI	Class II	Active
Ethilon	489T	FDA UDI	Class II	Active
E-Pack	7772E	FDA UDI	Class II	Unknown
E-Pack	9499E	FDA UDI	Class II	Unknown
Pronova	M3725	FDA UDI	Class II	Active
Coated VICRYL	DC381	FDA UDI	Class II	Active
Ethicon	D8951	FDA UDI	Class II	Active
Prolene	D8651	FDA UDI	Class II	Active
Prolene	8767	FDA UDI	Class II	Active
Vicryl	V402G	FDA UDI	Class II	Active
E-Pack	8897E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP727D	FDA UDI	Class II	Active
Stratafix	SXPP1A420	FDA UDI	Class II	Active
Coated VICRYL	VCP980H	FDA UDI	Class II	Active
Coated VICRYL	VCP634T	FDA UDI	Class II	Active
Coated VICRYL	VCPB259H	FDA UDI	Class II	Active
Monocryl	MCP463G	FDA UDI	Class II	Active
Ethilon	G695G	FDA UDI	Class II	Active
Coated VICRYL	VCP452H	FDA UDI	Class II	Active
E-Pack	9012E	FDA UDI	Class II	Unknown
Coated VICRYL	D8192	FDA UDI	Class II	Active
Pronova	3805H	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