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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 1 of 117

Device	Model / Reference	Registries	Class	Status
Urinary Placement Catheter	UPC414	EUDAMED	Class I	Active
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices	K252047	FDA 510(k)	Class II	Active
Stratafix	SXMP1B421	FDA UDI	Class II	Active
Pds	D7532	FDA UDI	Class II	Active
Pronova	3806H	FDA UDI	Class II	Active
Ethibond Excel	D10129	FDA UDI	Class II	Active
Coated VICRYL	J511G	FDA UDI	Class II	Active
E-Pack	5976E	FDA UDI	Class II	Unknown
Pronova	3776H	FDA UDI	Class II	Active
Prolene	M8737	FDA UDI	Class II	Active
Surgicel Fibrillar	431962	FDA UDI	Class III	Unknown
Coated VICRYL	VCP315H	FDA UDI	Class II	Active
Monocryl	D10100	FDA UDI	Class II	Active
Prolene	EPM8731	FDA UDI	Class II	Active
Coated VICRYL	J843G	FDA UDI	Class II	Active
Coated VICRYL	D9754	FDA UDI	Class II	Active
Coated VICRYL	J657G	FDA UDI	Class II	Active
Prolene	D8695	FDA UDI	Class II	Active
Ethicon	991H	FDA UDI	Class II	Active
Coated VICRYL	VCP433H	FDA UDI	Class II	Active
Mersilene	D2497	FDA UDI	Class II	Active
Perma-Hand	K870H	FDA UDI	Class II	Active
Prolene	D9774	FDA UDI	Class II	Active
Coated VICRYL	VCP695H	FDA UDI	Class II	Active
Prolene	M8721	FDA UDI	Class II	Active
Stratafix	SXPP1A421	FDA UDI	Class II	Active
Stratafix	SXMP1B415	FDA UDI	Class II	Active
Vicryl Rapide	VR497	FDA UDI	Class II	Active
Coated VICRYL	D9706	FDA UDI	Class II	Active
E-Pack	8359E	FDA UDI	Class II	Unknown
Mersilene	D8062	FDA UDI	Class II	Active
E-Pack	4178E	FDA UDI	Class II	Unknown
Perma-Hand	SA6H	FDA UDI	Class II	Active
Coated VICRYL	J718T	FDA UDI	Class II	Active
Prolene	8206H	FDA UDI	Class II	Active
Stratafix	SXPP2B300	FDA UDI	Class II	Active
Coated VICRYL	J547G	FDA UDI	Class II	Active
Perma-Hand	1690H	FDA UDI	Class II	Active
Ethilon	G698G	FDA UDI	Class II	Active
Prolene	M8718	FDA UDI	Class II	Active
Pronova	PNM3703	FDA UDI	Class II	Active
Coated VICRYL	J583G	FDA UDI	Class II	Active
E-Pack	8513E	FDA UDI	Class II	Unknown
Coated VICRYL	D10149	FDA UDI	Class II	Active
Coated VICRYL	J693H	FDA UDI	Class II	Active
Ethicon Omnex	4901	FDA UDI	Class III	Unknown
Mersilene	D9212	FDA UDI	Class II	Active
E-Pack	9184E	FDA UDI	Class II	Unknown
Pds	D9424	FDA UDI	Class II	Active
E-Pack	8865E	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