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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 11 of 117

Device	Model / Reference	Registries	Class	Status
Ethibond Excel	D5844	FDA UDI	Class II	Active
Prolene	C822G	FDA UDI	Class II	Active
E-Pack	8064E	FDA UDI	Class II	Unknown
Ethicon	1824H	FDA UDI	Class II	Active
Ethilon	1665G	FDA UDI	Class II	Active
Pds	ZB370	FDA UDI	Class II	Active
Prolene	DC373	FDA UDI	Class II	Active
Vicryl	JB259H	FDA UDI	Class II	Active
Monocryl	YY32G	FDA UDI	Class II	Active
Coated VICRYL	D6098	FDA UDI	Class II	Active
Coated VICRYL	J700D	FDA UDI	Class II	Active
Ethibond Excel	D5844N	FDA UDI	Class II	Active
Ethibond Excel	PXX86	FDA UDI	Class II	Active
E-Pack	6837E	FDA UDI	Class II	Unknown
E-Pack	9711E	FDA UDI	Class II	Unknown
Ethibond Excel	D10067	FDA UDI	Class II	Active
Coated VICRYL	VCP335H	FDA UDI	Class II	Active
Ethibond Excel	SXP77	FDA UDI	Class II	Active
Ethibond Excel	D9913	FDA UDI	Class II	Active
Coated VICRYL	VCP335H	FDA UDI	Class II	Unknown
Perma-Hand	1677G	FDA UDI	Class II	Active
Coated VICRYL	VCPB765D	FDA UDI	Class II	Active
Mersilene	D5951	FDA UDI	Class II	Active
Stratafix	SXPP1A435	FDA UDI	Class II	Active
Pds	PDP442H	FDA UDI	Class II	Active
Prolene	EP8704H	FDA UDI	Class II	Active
E-Pack	9587E	FDA UDI	Class II	Unknown
E-Pack	9705E	FDA UDI	Class II	Unknown
Pds	Z740D	FDA UDI	Class II	Active
Coated VICRYL	VCP358H	FDA UDI	Class II	Active
Prolene	C841G	FDA UDI	Class II	Active
E-Pack	9889E	FDA UDI	Class II	Unknown
Ethicon	D9499	FDA UDI	Class II	Active
Stratafix	SXPP1A425	FDA UDI	Class II	Active
Coated VICRYL	VCP959H	FDA UDI	Class II	Active
Prolene	EP8753H	FDA UDI	Class II	Active
Prolene	W8813	FDA UDI	Class II	Active
Pds	PDP397H	FDA UDI	Class II	Active
Ethilon	2890G	FDA UDI	Class II	Active
Pds	PDPB880G	FDA UDI	Class II	Active
Ethibond Excel	PX1007N	FDA UDI	Class II	Active
Prolene	EPM8703	FDA UDI	Class II	Active
Endoloop	EZ10G	FDA UDI	Class II	Active
E-Pack	9295E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP104G	FDA UDI	Class II	Active
Ethicon	D10000	FDA UDI	Class II	Active
Coated VICRYL	J596H	FDA UDI	Class II	Active
E-Pack	7399E	FDA UDI	Class II	Unknown
E-Pack	8651E	FDA UDI	Class II	Unknown
E-Pack	8896E	FDA UDI	Class II	Unknown

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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