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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 5 of 117

Device	Model / Reference	Registries	Class	Status
Ethicon	2643G	FDA UDI	Class II	Active
E-Pack	8406E	FDA UDI	Class II	Unknown
Coated VICRYL	J579G	FDA UDI	Class II	Active
Ethibond Excel	D9876N	FDA UDI	Class II	Active
Nurolon	D4571	FDA UDI	Class II	Active
Pds	PDP739D	FDA UDI	Class II	Active
E-Pack	8864E	FDA UDI	Class II	Unknown
E-Pack	8480E	FDA UDI	Class II	Unknown
Ethilon	1854G	FDA UDI	Class II	Active
Ethicon	SG13T	FDA UDI	Class II	Active
Monocryl	Y344H	FDA UDI	Class II	Active
Ethibond Excel	D8492N	FDA UDI	Class II	Active
E-Pack	8857E	FDA UDI	Class II	Unknown
Ethilon	1663H	FDA UDI	Class II	Active
Ethibond Excel	D8737	FDA UDI	Class II	Active
Pds	D10102	FDA UDI	Class II	Active
Perma-Hand	D9659	FDA UDI	Class II	Active
Ethilon	D4734	FDA UDI	Class II	Active
E-Pack	8236E	FDA UDI	Class II	Unknown
E-Pack	9210E	FDA UDI	Class II	Unknown
E-Pack	7254E	FDA UDI	Class II	Unknown
Ethibond Excel	PXX22N	FDA UDI	Class II	Active
Ethicon	752G	FDA UDI	Class II	Active
Coated VICRYL	D10144	FDA UDI	Class II	Active
Coated VICRYL	J266H	FDA UDI	Class II	Active
Ethilon	D10199	FDA UDI	Class II	Active
E-Pack	8563E	FDA UDI	Class II	Unknown
Coated VICRYL	J357H	FDA UDI	Class II	Active
Stratafix	SXMP1B108	FDA UDI	Class II	Active
Stratafix	SXMP2B408	FDA UDI	Class II	Active
Pds	D8173	FDA UDI	Class II	Active
E-Pack	7486E	FDA UDI	Class II	Unknown
Coated VICRYL	J726D	FDA UDI	Class II	Active
Pds	PDP416H	FDA UDI	Class II	Active
E-Pack	8721E	FDA UDI	Class II	Unknown
Perma-Hand	SA63T	FDA UDI	Class II	Active
Ethilon	G662G	FDA UDI	Class II	Active
Mersilene	R665H	FDA UDI	Class II	Active
E-Pack	9524E	FDA UDI	Class II	Unknown
Ethibond Excel	D5901	FDA UDI	Class II	Active
Stratafix	SXMP1B444	FDA UDI	Class II	Active
Surgicel	3123SPEA	FDA UDI	Class III	Active
Mersilene	R633H	FDA UDI	Class II	Active
Coated VICRYL	J603H	FDA UDI	Class II	Active
Ethilon	1669H	FDA UDI	Class II	Active
Endoknot	ZK10C	FDA UDI	Class II	Unknown
Pds	Z761D	FDA UDI	Class II	Active
E-Pack	9036E	FDA UDI	Class II	Unknown
Stratafix	SXPP1B112	FDA UDI	Class II	Active
Pds	Z464H	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