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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 24 of 117

Device	Model / Reference	Registries	Class	Status
Prolene	M8752	FDA UDI	Class II	Active
Perma-Hand	641G	FDA UDI	Class II	Active
Stratafix	SXPP2B415	FDA UDI	Class II	Active
Pds	Z513ZG	FDA UDI	Class II	Active
Perma-Hand	7733G	FDA UDI	Class II	Active
Coated VICRYL	J459H	FDA UDI	Class II	Active
E-Pack	8209E	FDA UDI	Class II	Unknown
Mersilene	R647H	FDA UDI	Class II	Active
Prolene	D9662	FDA UDI	Class II	Active
E-Pack	6393E	FDA UDI	Class II	Unknown
Ethibond Excel	PXX79N	FDA UDI	Class II	Active
Stratafix	SXPP1B431	FDA UDI	Class II	Active
Ethicon	D10191	FDA UDI	Class II	Active
Prolene	8952H	FDA UDI	Class II	Active
E-Pack	9685E	FDA UDI	Class II	Unknown
Coated VICRYL	VCPB840D	FDA UDI	Class II	Active
Stratafix	SXPP1B421	FDA UDI	Class II	Active
Mersilene	R833H	FDA UDI	Class II	Active
Monocryl	Y682H	FDA UDI	Class II	Active
Stratafix	SXPP1B107	FDA UDI	Class II	Active
E-Pack	8738E	FDA UDI	Class II	Unknown
Monocryl	MCP339H	FDA UDI	Class II	Active
Ethibond Excel	D9132	FDA UDI	Class II	Active
Pds	D10174	FDA UDI	Class II	Active
Stratafix	SXPP2B434	FDA UDI	Class II	Active
Monocryl	YB978	FDA UDI	Class II	Active
Ethicon	913H	FDA UDI	Class II	Active
Ethicon	PCP20	FDA UDI	Class II	Active
Ethibond Excel	X844H	FDA UDI	Class II	Active
Prolene	8682H	FDA UDI	Class II	Active
E-Pack	9276E	FDA UDI	Class II	Unknown
Pds	Z334H	FDA UDI	Class II	Active
Ethicon	D5949	FDA UDI	Class II	Unknown
Pds	D6410	FDA UDI	Class II	Active
Ethilon	1698H	FDA UDI	Class II	Active
Coated VICRYL	VCP269H	FDA UDI	Class II	Active
Prolene	D6176	FDA UDI	Class II	Active
Pds	PDPB346	FDA UDI	Class II	Active
Ethibond Excel	PXX77	FDA UDI	Class II	Active
Stratafix	SXMP1B106	FDA UDI	Class II	Active
Coated VICRYL	J426H	FDA UDI	Class II	Active
Coated VICRYL	VCP392ZH	FDA UDI	Class II	Active
Stratafix	SXMP2B409	FDA UDI	Class II	Active
Pds	ZB346	FDA UDI	Class II	Active
E-Pack	8367E	FDA UDI	Class II	Unknown
Prolene	8558H	FDA UDI	Class II	Active
E-Pack	4984E	FDA UDI	Class II	Unknown
E-Pack	7590E	FDA UDI	Class II	Unknown
Coated VICRYL	J497H	FDA UDI	Class II	Active
Prolene	8557H	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