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Ethicon Inc.

United States·US-MF-000013111

Last updated September 17, 2026

What Ethicon Inc. makes

Ethicon Inc. manufactures surgical sutures and related devices, including monofilament and multifilament sutures made from polyolefin/fluoropolymer, polyester, nylon, and bioabsorbable materials such as chromic catgut. The company also produces knotless tissue control devices like STRATAFIX Symmetric PDS Plus and coated absorbable sutures such as Coated VICRYL and MONOCRYL.

The manufacturer's devices are classified as Class I, II, and III and are listed in regulatory registries including EUDAMED, FDA 510(k), and FDA UDI. Ethicon Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Ethicon Inc. manufacture?

Ethicon Inc. manufactures surgical sutures and related devices, including monofilament and multifilament sutures made from polyolefin/fluoropolymer, polyester, nylon, and bioabsorbable materials such as chromic catgut, as well as knotless tissue control devices like STRATAFIX Symmetric PDS Plus and coated absorbable sutures such as Coated VICRYL and MONOCRYL.

Where is Ethicon Inc. based?

Ethicon Inc. is based in the United States, as stated in the manufacturer's summary and country field.

Which regulatory registries list Ethicon Inc.'s devices?

Ethicon Inc.'s devices are listed in regulatory registries including EUDAMED, FDA 510(k), and FDA UDI, as specified in the LISTED IN field and confirmed in the summary.

How are Ethicon Inc.'s devices classified?

Ethicon Inc.'s devices are classified as Class I, Class II, and Class III, as indicated in the DEVICE CLASSES field and reiterated in the summary, reflecting varying levels of regulatory control based on device risk.

AI-generated from registry data and not verified by a human reviewer.

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 39 of 117

Device	Model / Reference	Registries	Class	Status
E-Pack	8863E	FDA UDI	Class II	Unknown
Ethilon	9002G	FDA UDI	Class II	Active
Stratafix	SXPP2B407	FDA UDI	Class II	Active
Coated VICRYL	VCP493G	FDA UDI	Class II	Active
Pds	PDPB347H	FDA UDI	Class II	Active
E-Pack	8873E	FDA UDI	Class II	Unknown
Ethilon	D9180	FDA UDI	Class II	Active
Perma-Hand	685G	FDA UDI	Class II	Active
PDS Plates	ZX5U	FDA UDI	Class II	Active
Monocryl	YB257H	FDA UDI	Class II	Active
Prolene	D9422	FDA UDI	Class II	Active
Stratafix	SXMP1B416	FDA UDI	Class II	Active
Coated VICRYL	D7510	FDA UDI	Class II	Active
Ethilon	F2423H	FDA UDI	Class II	Active
Monocryl	Y377H	FDA UDI	Class II	Active
E-Pack	6825E	FDA UDI	Class II	Unknown
Prolene	D5341	FDA UDI	Class II	Active
Vicryl Rapide	VR416	FDA UDI	Class II	Active
Ethicon	G172H	FDA UDI	Class II	Active
Ethibond Excel	D9941	FDA UDI	Class II	Active
E-Pack	8680E	FDA UDI	Class II	Unknown
E-Pack	9451E	FDA UDI	Class II	Unknown
Ethibond Excel	CX14D	FDA UDI	Class II	Active
Coated VICRYL	J472H	FDA UDI	Class II	Active
Prolene	8977H	FDA UDI	Class II	Active
Ethicon	5503T	FDA UDI	Class II	Active
Perma-Hand	7734G	FDA UDI	Class II	Active
E-Pack	3492E	FDA UDI	Class II	Unknown
Prolene	EPM8776	FDA UDI	Class II	Active
E-Pack	9463E	FDA UDI	Class II	Unknown
Prolene	8756H	FDA UDI	Class II	Active
Prolene	M8356	FDA UDI	Class II	Active
Coated VICRYL	VCP774D	FDA UDI	Class II	Active
Ethibond Excel	D10069	FDA UDI	Class II	Active
E-Pack	9493E	FDA UDI	Class II	Unknown
Ethibond Excel	10X72N	FDA UDI	Class II	Active
Stratafix	SXPP1B433	FDA UDI	Class II	Active
Coated VICRYL	VCPB958H	FDA UDI	Class II	Active
Ethicon	G128H	FDA UDI	Class II	Active
E-Pack	8629E	FDA UDI	Class II	Unknown
E-Pack	7258E	FDA UDI	Class II	Unknown
Coated VICRYL	J334H	FDA UDI	Class II	Active
Pds	PDP795D	FDA UDI	Class II	Active
E-Pack	7776E	FDA UDI	Class II	Unknown
E-Pack	9178E	FDA UDI	Class II	Unknown
E-Pack	8676E	FDA UDI	Class II	Unknown
Prolene	D7889	FDA UDI	Class II	Active
Ethibond Excel	D5977	FDA UDI	Class II	Active
E-Pack	8948E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP716T	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Importers

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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.

There are 15 recall records for Ethicon Inc., with the earliest initiated on 2023-03-31 and the most recent on 2025-08-15. The statuses recorded for these recalls are open and classified. The reasons given include complaints about needle pull-off and suture degradation, potential for barb non-engagement, degraded and unusable sutures due to exposed environmental conditions compromising sterility, internal testing showing some PDS II sutures did not meet tensile strength requirements, open seals on primary packaging due to a manufacturing issue on a specific machine that could breach sterility, suture breakage during intra-operative use affecting tissue approximation or ligation, and holes in primary packaging from a specific packaging machine compromising product sterility.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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