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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 38 of 117

Device	Model / Reference	Registries	Class	Status
Ethilon	F3234BH	FDA UDI	Class II	Active
Pronova	PNM3702	FDA UDI	Class II	Active
E-Pack	9156E	FDA UDI	Class II	Unknown
Stratafix	SXPP1B455	FDA UDI	Class II	Active
Ethicon	1653G	FDA UDI	Class II	Active
Coated VICRYL	J615H	FDA UDI	Class II	Active
E-Pack	9906E	FDA UDI	Class II	Unknown
Monocryl	Y936H	FDA UDI	Class II	Active
E-Pack	8306E	FDA UDI	Class II	Unknown
Ethicon Securestrap	STRAP12R	FDA UDI	Class II	Active
Stratafix	SXPP2B101	FDA UDI	Class II	Active
Perma-Hand	C003D	FDA UDI	Class II	Active
Prolene	8805H	FDA UDI	Class II	Active
Pds	Z123H	FDA UDI	Class II	Active
Coated VICRYL	J214H	FDA UDI	Class II	Active
Stratafix	SXPP1B116	FDA UDI	Class II	Active
E-Pack	8626E	FDA UDI	Class II	Unknown
Coated VICRYL	J552G	FDA UDI	Class II	Active
E-Pack	8237E	FDA UDI	Class II	Unknown
E-Pack	8793E	FDA UDI	Class II	Unknown
Coated VICRYL	J269H	FDA UDI	Class II	Active
Prolene	8422H	FDA UDI	Class II	Active
Ethibond Excel	10X82	FDA UDI	Class II	Active
E-Pack	9848E	FDA UDI	Class II	Unknown
Coated VICRYL	JB839	FDA UDI	Class II	Active
Prolene	8695G	FDA UDI	Class II	Active
E-Pack	7365E	FDA UDI	Class II	Unknown
Prolene	D9199	FDA UDI	Class II	Active
Coated VICRYL	J486H	FDA UDI	Class II	Active
Coated VICRYL	VCP764D	FDA UDI	Class II	Active
E-Pack	9214E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP105G	FDA UDI	Class II	Active
Perma-Hand	W578H	FDA UDI	Class II	Active
Perma-Hand	783G	FDA UDI	Class II	Active
Coated VICRYL	VCP823G	FDA UDI	Class II	Active
E-Pack	7639E	FDA UDI	Class II	Unknown
Coated VICRYL	VCP453H	FDA UDI	Class II	Unknown
Ethilon	1865G	FDA UDI	Class II	Active
Prolene	D9124	FDA UDI	Class II	Active
E-Pack	8892E	FDA UDI	Class II	Unknown
Coated VICRYL	J750T	FDA UDI	Class II	Active
Ethilon	9030G	FDA UDI	Class II	Active
E-Pack	5880E	FDA UDI	Class II	Unknown
Ethibond Excel	D6798	FDA UDI	Class II	Active
E-Pack	8552E	FDA UDI	Class II	Unknown
Monocryl	YB257	FDA UDI	Class II	Active
Nurolon	5424H	FDA UDI	Class II	Active
Prolene	M8304	FDA UDI	Class II	Active
Coated VICRYL	J283G	FDA UDI	Class II	Active
Prolene	8726H	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Importers

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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