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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 17 of 117

Device	Model / Reference	Registries	Class	Status
E-Pack	7473E	FDA UDI	Class II	Unknown
Coated VICRYL	J834G	FDA UDI	Class II	Active
Prolene	D9516	FDA UDI	Class II	Active
Prolene	8636G	FDA UDI	Class II	Active
E-Pack	9336E	FDA UDI	Class II	Unknown
Ethibond Excel	MX553	FDA UDI	Class II	Active
E-Pack	9134E	FDA UDI	Class II	Unknown
Prolene	C826G	FDA UDI	Class II	Active
Ethibond Excel	D9607N	FDA UDI	Class II	Active
Coated VICRYL	D9684	FDA UDI	Class II	Active
E-Pack	8507E	FDA UDI	Class II	Unknown
Coated VICRYL	J568H	FDA UDI	Class II	Active
Vicryl Rapide	VR834	FDA UDI	Class II	Active
E-Pack	9404E	FDA UDI	Class II	Unknown
Prolene	EPM8734	FDA UDI	Class II	Active
Perma-Hand	M14T	FDA UDI	Class II	Active
Coated VICRYL	JJ81G	FDA UDI	Class II	Active
Mersilene	DC261	FDA UDI	Class II	Active
E-Pack	8360E	FDA UDI	Class II	Unknown
Coated VICRYL	D8265	FDA UDI	Class II	Active
Stratafix	SXPP1B201	FDA UDI	Class II	Active
Coated VICRYL	VCP259H	FDA UDI	Class II	Active
Ethicon	TPW32	FDA UDI	Class II	Active
Perma-Hand	N266H	FDA UDI	Class II	Active
E-Pack	8622E	FDA UDI	Class II	Unknown
E-Pack	9699E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP753D	FDA UDI	Class II	Active
Prolene	8701H	FDA UDI	Class II	Active
E-Pack	9435E	FDA UDI	Class II	Unknown
Prolene	EPM8706G	FDA UDI	Class II	Unknown
Ethibond Excel	MX523	FDA UDI	Class II	Active
Mersilene	D3909	FDA UDI	Class II	Active
E-Pack	8113E	FDA UDI	Class II	Unknown
E-Pack	9219E	FDA UDI	Class II	Unknown
Ethibond Excel	D9327	FDA UDI	Class II	Active
Pronova	3555H	FDA UDI	Class II	Active
Prolene	OS8752H	FDA UDI	Class II	Active
Coated VICRYL	VCP698H	FDA UDI	Class II	Active
E-Pack	7202E	FDA UDI	Class II	Unknown
Ethicon	VSTAS1E	FDA UDI	Class II	Active
Coated VICRYL	J931H	FDA UDI	Class II	Active
Ethibond Excel	D9379	FDA UDI	Class II	Active
Coated VICRYL	J204G	FDA UDI	Class II	Active
Perma-Hand	D7703	FDA UDI	Class II	Active
Monocryl	Y527H	FDA UDI	Class II	Active
Coated VICRYL	D7795	FDA UDI	Class II	Active
E-Pack	6745E	FDA UDI	Class II	Unknown
Monocryl	Y987H	FDA UDI	Class II	Active
Coated VICRYL	VCP316H	FDA UDI	Class II	Unknown
Coated VICRYL	VCP493H	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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