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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 35 of 117

Device	Model / Reference	Registries	Class	Status
Coated VICRYL	J835G	FDA UDI	Class II	Active
Coated VICRYL	J523H	FDA UDI	Class II	Active
E-Pack	8693E	FDA UDI	Class II	Unknown
Perma-Hand	SA74H	FDA UDI	Class II	Active
Ethicon	U11T	FDA UDI	Class I	Unknown
Ethibond Excel	D8558	FDA UDI	Class II	Active
Ethicon	887H	FDA UDI	Class II	Active
E-Pack	7953E	FDA UDI	Class II	Unknown
E-Pack	8009E	FDA UDI	Class II	Unknown
Ethilon	490T	FDA UDI	Class II	Active
Monocryl	YB947	FDA UDI	Class II	Active
Pds	D8081	FDA UDI	Class II	Active
Monocryl	D8550	FDA UDI	Class II	Active
Coated VICRYL	D10083	FDA UDI	Class II	Active
Coated VICRYL	VCP304H	FDA UDI	Class II	Active
Coated VICRYL	VCP789D	FDA UDI	Class II	Active
Gynecare Versapoint	00466	FDA UDI	Class II	Unknown
Coated VICRYL	VCP434H	FDA UDI	Class II	Active
Coated VICRYL	VCP531H	FDA UDI	Class II	Active
Coated VICRYL	J880T	FDA UDI	Class II	Active
Mersilene	D2726	FDA UDI	Class II	Active
Monocryl	YB416	FDA UDI	Class II	Active
E-Pack	8173E	FDA UDI	Class II	Unknown
Coated VICRYL	J370H	FDA UDI	Class II	Active
E-Pack	8625E	FDA UDI	Class II	Unknown
Coated VICRYL	D7856	FDA UDI	Class II	Active
Monocryl	D10197	FDA UDI	Class II	Active
E-Pack	7985E	FDA UDI	Class II	Unknown
Coated VICRYL	D8768	FDA UDI	Class II	Active
Coated VICRYL	VCPB340H	FDA UDI	Class II	Active
Ethicon	D8720	FDA UDI	Class II	Active
Ethicon	CC02G	FDA UDI	Class II	Active
Pronova	PN3321H	FDA UDI	Class II	Active
Stratafix	SXMP1B430	FDA UDI	Class II	Active
Vicryl Rapide	VR9580	FDA UDI	Class II	Active
E-Pack	9031E	FDA UDI	Class II	Unknown
Mersilene	D8113	FDA UDI	Class II	Active
Stratafix	SXPP1A439	FDA UDI	Class II	Active
Coated VICRYL	VCP421H	FDA UDI	Class II	Active
E-Pack	6600E	FDA UDI	Class II	Unknown
Ethilon	F3232BH	FDA UDI	Class II	Active
Ethibond Excel	PXX82N	FDA UDI	Class II	Active
Prolene	W8475G	FDA UDI	Class II	Active
Stratafix	SXPP1A200	FDA UDI	Class II	Active
Prolene	PB31H	FDA UDI	Class II	Active
Stratafix	SXMP1B425	FDA UDI	Class II	Active
E-Pack	9693E	FDA UDI	Class II	Unknown
E-Pack	9421E	FDA UDI	Class II	Unknown
Perma-Hand	D7793	FDA UDI	Class II	Active
Coated VICRYL	D9762	FDA UDI	Class II	Active

Related Companies

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Notified Bodies

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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