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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 33 of 117

Device	Model / Reference	Registries	Class	Status
Monocryl	YB946	FDA UDI	Class II	Active
Prolene	D9691	FDA UDI	Class II	Active
Ethibond Excel	D5169	FDA UDI	Class II	Active
Prolene	9091G	FDA UDI	Class II	Active
E-Pack	8350E	FDA UDI	Class II	Unknown
E-Pack	9531E	FDA UDI	Class II	Unknown
E-Pack	8723E	FDA UDI	Class II	Unknown
Coated VICRYL	J275H	FDA UDI	Class II	Active
Ethicon	N862H	FDA UDI	Class II	Active
Ethibond Excel	D7447	FDA UDI	Class II	Active
Prolene	D10088	FDA UDI	Class II	Active
E-Pack	9063E	FDA UDI	Class II	Unknown
Pds	PDP497G	FDA UDI	Class II	Active
Prolene	D9980	FDA UDI	Class II	Active
Ethibond Excel	D7129N	FDA UDI	Class II	Active
Monocryl	YY31D	FDA UDI	Class II	Active
Ethilon	668G	FDA UDI	Class II	Active
Stratafix	SXMP1B116	FDA UDI	Class II	Active
Ethibond Excel	X581H	FDA UDI	Class II	Active
Pds	PDP114H	FDA UDI	Class II	Active
Perma-Hand	SA63H	FDA UDI	Class II	Active
Ethicon	D9435	FDA UDI	Class II	Active
Perma-Hand	1639G	FDA UDI	Class II	Active
Ethilon	698H	FDA UDI	Class II	Active
Pds	PDPB371	FDA UDI	Class II	Active
Pds	D9967	FDA UDI	Class II	Active
Pds	PDP683G	FDA UDI	Class II	Active
Coated VICRYL	J416H	FDA UDI	Class II	Active
Ethilon	667G	FDA UDI	Class II	Active
E-Pack	9453E	FDA UDI	Class II	Unknown
Pds	Z507G	FDA UDI	Class II	Active
Mersilene	D5789	FDA UDI	Class II	Active
Prolene	EPM8753	FDA UDI	Class II	Active
Ethibond Excel	X184H	FDA UDI	Class II	Active
Pds	PDPB991G	FDA UDI	Class II	Active
Ethibond Excel	X32071H	FDA UDI	Class II	Active
Coated VICRYL	D10082	FDA UDI	Class II	Active
Nurolon	D5620	FDA UDI	Class II	Active
E-Pack	9148E	FDA UDI	Class II	Unknown
Ethibond Excel	D9672	FDA UDI	Class II	Active
Pronova	3725H	FDA UDI	Class II	Active
Coated VICRYL	JB341H	FDA UDI	Class II	Active
Prolene	EPH8716H	FDA UDI	Class II	Active
Coated VICRYL	VCP752D	FDA UDI	Class II	Active
Prolene	D6808	FDA UDI	Class II	Active
Stratafix	SXMP2B413	FDA UDI	Class II	Active
PDS Plates	ZX7	FDA UDI	Class II	Active
Coated VICRYL	VCP443H	FDA UDI	Class II	Unknown
Monocryl	Y4946H	FDA UDI	Class II	Active
E-Pack	9085E	FDA UDI	Class II	Unknown

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