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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 2 of 117

Device	Model / Reference	Registries	Class	Status
Pds	PDP303H	FDA UDI	Class II	Active
Prolene	W8440G	FDA UDI	Class II	Active
Perma-Hand	K881H	FDA UDI	Class II	Active
Ethicon	G152H	FDA UDI	Class II	Active
Ethibond Excel	D9940	FDA UDI	Class II	Active
Prolene	C827G	FDA UDI	Class II	Active
Prolene	8978H	FDA UDI	Class II	Active
E-Pack	9600E	FDA UDI	Class II	Unknown
Coated VICRYL	J329H	FDA UDI	Class II	Active
Coated VICRYL	J111T	FDA UDI	Class II	Active
E-Pack	9937E	FDA UDI	Class II	Unknown
E-Pack	9809E	FDA UDI	Class II	Unknown
E-Pack	9636E	FDA UDI	Class II	Unknown
E-Pack	8815E	FDA UDI	Class II	Unknown
Ethilon	824G	FDA UDI	Class II	Active
Ethicon	795G	FDA UDI	Class II	Active
Coated VICRYL	V549G	FDA UDI	Class II	Active
Ethicon	D6405	FDA UDI	Class II	Active
Perma-Hand	18515G	FDA UDI	Class II	Active
E-Pack	9820E	FDA UDI	Class II	Unknown
E-Pack	9603E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP451H	FDA UDI	Class II	Unknown
Monocryl	Y738D	FDA UDI	Class II	Active
Coated VICRYL	VCPP71D	FDA UDI	Class II	Active
Coated VICRYL	J422H	FDA UDI	Class II	Active
Pds	D7535	FDA UDI	Class II	Active
Coated VICRYL	VCP322H	FDA UDI	Class II	Unknown
E-Pack	9844E	FDA UDI	Class II	Unknown
Ethibond Excel	SXX43	FDA UDI	Class II	Active
Ethicon	M652G	FDA UDI	Class II	Active
Stratafix	SXPP1B105	FDA UDI	Class II	Active
Coated VICRYL	VCP328H	FDA UDI	Class II	Active
Ethibond Excel	D9329	FDA UDI	Class II	Active
Coated VICRYL	J885G	FDA UDI	Class II	Active
Prolene	EPM8701	FDA UDI	Class II	Active
Prolene	D8631	FDA UDI	Class II	Active
Ethicon	CC01G	FDA UDI	Class II	Active
Prolene	8976H	FDA UDI	Class II	Active
Monocryl	Y340H	FDA UDI	Class II	Active
E-Pack	7369E	FDA UDI	Class II	Unknown
Ethibond Excel	BE3294G	FDA UDI	Class II	Active
Ethilon	2815G	FDA UDI	Class II	Active
Ethilon	1714G	FDA UDI	Class II	Active
Ethilon	D9944	FDA UDI	Class II	Active
Coated VICRYL	D6428	FDA UDI	Class II	Active
E-Pack	8260E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP615H	FDA UDI	Class II	Active
Coated VICRYL	J646H	FDA UDI	Class II	Active
Coated VICRYL	J974G	FDA UDI	Class II	Active
Ethibond Excel	D9646	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