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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 14 of 117

Device	Model / Reference	Registries	Class	Status
Pds	ZB739D	FDA UDI	Class II	Active
Ethicon	3811T	FDA UDI	Class II	Active
Ethilon	825G	FDA UDI	Class II	Active
Coated VICRYL	VCP946H	FDA UDI	Class II	Unknown
Vicryl Rapide	VR917	FDA UDI	Class II	Active
Ethibond Excel	D6940	FDA UDI	Class II	Active
Stratafix	SXMP1B120	FDA UDI	Class II	Active
Coated VICRYL	J427H	FDA UDI	Class II	Active
Pds	PDPB751D	FDA UDI	Class II	Active
Coated VICRYL	D7585	FDA UDI	Class II	Active
Prolene	8434H	FDA UDI	Class II	Active
Stratafix	SXPP2B435	FDA UDI	Class II	Active
Coated VICRYL	D7565	FDA UDI	Class II	Active
Prolene	D8441	FDA UDI	Class II	Active
Monocryl	D9158	FDA UDI	Class II	Active
Ethicon	D4568	FDA UDI	Class II	Active
Pronova	3703H	FDA UDI	Class II	Active
Stratafix	SXMP2B151	FDA UDI	Class II	Active
Stratafix	SXPP1A205	FDA UDI	Class II	Active
Vicryl Rapide	VR932	FDA UDI	Class II	Active
Ethi-Pak	DS28	FDA UDI	Class II	Active
Ethilon	EH7143BH	FDA UDI	Class II	Active
Coated VICRYL	VCP824G	FDA UDI	Class II	Active
Ethicon	D8005	FDA UDI	Class II	Active
Prolene	D8320	FDA UDI	Class II	Active
Pds	PDPB316H	FDA UDI	Class II	Active
Monocryl	D8797	FDA UDI	Class II	Active
Perma-Hand	W604G	FDA UDI	Class II	Active
Coated VICRYL	VCP339H	FDA UDI	Class II	Active
E-Pack	7454E	FDA UDI	Class II	Unknown
Prolene	M8747	FDA UDI	Class II	Active
E-Pack	9414E	FDA UDI	Class II	Unknown
Monocryl	Y339H	FDA UDI	Class II	Active
Coated VICRYL	VCPB650G	FDA UDI	Class II	Active
Prolene	W295H	FDA UDI	Class II	Active
Monocryl	D8291	FDA UDI	Class II	Active
Pds	Z126H	FDA UDI	Class II	Active
Coated VICRYL	VCP305H	FDA UDI	Class II	Active
Monocryl	Y935H	FDA UDI	Class II	Active
E-Pack	8794E	FDA UDI	Class II	Unknown
Ethilon	1668G	FDA UDI	Class II	Active
Ethilon	F2413H	FDA UDI	Class II	Active
Ethilon	9031G	FDA UDI	Class II	Active
Coated VICRYL	VCP306H	FDA UDI	Class II	Active
Coated VICRYL	JJ41G	FDA UDI	Class II	Active
Ethibond Excel	D9263	FDA UDI	Class II	Active
Perma-Hand	K942H	FDA UDI	Class II	Active
E-Pack	8797E	FDA UDI	Class II	Unknown
Perma-Hand	680H	FDA UDI	Class II	Active
Prolene	8843H	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