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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 13 of 117

Device	Model / Reference	Registries	Class	Status
PDS Plates	ZX5	FDA UDI	Class II	Active
E-Pack	8920E	FDA UDI	Class II	Unknown
Ethicon	SG2T	FDA UDI	Class II	Active
Coated VICRYL	J849G	FDA UDI	Class II	Active
Coated VICRYL	J910T	FDA UDI	Class II	Active
Stratafix	SXPP1B404	FDA UDI	Class II	Active
E-Pack	8539E	FDA UDI	Class II	Unknown
Ethibond Excel	PX62H	FDA UDI	Class II	Active
E-Pack	9317E	FDA UDI	Class II	Unknown
E-Pack	8604E	FDA UDI	Class II	Unknown
E-Pack	8383E	FDA UDI	Class II	Unknown
E-Pack	9597E	FDA UDI	Class II	Unknown
Monocryl	Y335H	FDA UDI	Class II	Active
Vicryl Rapide	VR944	FDA UDI	Class II	Active
Coated VICRYL	VCP486H	FDA UDI	Class II	Unknown
Ethibond Excel	X7909H	FDA UDI	Class II	Active
Monocryl	Y942H	FDA UDI	Class II	Active
Ethibond Excel	X663H	FDA UDI	Class II	Active
Coated VICRYL	J441H	FDA UDI	Class II	Active
Ethibond Excel	X559H	FDA UDI	Class II	Active
Coated VICRYL	VCP416H	FDA UDI	Class II	Unknown
Ethibond Excel	X580H	FDA UDI	Class II	Active
Ethicon	H823H	FDA UDI	Class II	Active
Prolene	PMXS	FDA UDI	Class II	Active
Biopatch	10152	FDA UDI	U	Active
E-Pack	9953E	FDA UDI	Class II	Unknown
Perma-Hand	675H	FDA UDI	Class II	Active
Prolene	8710H	FDA UDI	Class II	Active
Perma-Hand	714G	FDA UDI	Class II	Active
Perma-Hand	D7525	FDA UDI	Class II	Active
Prolene	EPM8751	FDA UDI	Class II	Active
Coated VICRYL	VCP762D	FDA UDI	Class II	Active
Coated VICRYL	VCP464G	FDA UDI	Class II	Active
Ethicon	D9621	FDA UDI	Class II	Active
Ethibond Excel	10X42N	FDA UDI	Class II	Active
Prolene	F2860H	FDA UDI	Class II	Active
Coated VICRYL	VCP845G	FDA UDI	Class II	Active
Monocryl	Y213H	FDA UDI	Class II	Active
Prolene	OSM8763	FDA UDI	Class II	Active
Ethibond Excel	D9942	FDA UDI	Class II	Active
Prolene	D8225	FDA UDI	Class II	Active
Prolene	PMXL	FDA UDI	Class II	Active
Pds	PDP358T	FDA UDI	Class II	Active
Ethibond Excel	D8150	FDA UDI	Class I	Active
Nurolon	C575D	FDA UDI	Class II	Active
Ethilon	D8112	FDA UDI	Class II	Active
Mersilene	D1841	FDA UDI	Class II	Active
Coated VICRYL	J643H	FDA UDI	Class II	Active
Nurolon	D9868	FDA UDI	Class II	Active
Pronova	3321H	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Importers

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Notified Bodies

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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