Ethicon Inc. surgical sutures and tissue control devices

Catalogue7,046

Page 1 of 40

Showing 1-50 of 7,046

EUDAMED certificates12

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

Notified body 2797 12 certificates

MDR 719610 Reissued

Quality management system EU MDR

Issued
4 Sep 2026

Expires
13 Oct 2031

Valid from
14 Oct 2026
MDR 753200 Reissued

Technical documentation EU MDR

Issued
9 Sep 2026

Expires
8 Sep 2031
MDR 753191 Supplemented

Technical documentation EU MDR

Issued
19 Jun 2026

Expires
19 Jul 2028

Reason
Other
MDR 753197 Supplemented

Technical documentation EU MDR

Issued
19 Jun 2026

Expires
19 Jul 2028

Reason
Other
MDR 719650 Supplemented

Technical documentation EU MDR

Issued
5 Jun 2026

Expires
4 Jul 2028

Reason
Other
MDR 719658 Supplemented

Technical documentation EU MDR

Issued
5 Jun 2026

Expires
4 Jul 2028

Reason
Other
MDR 753181 Supplemented

Technical documentation EU MDR

Issued
19 Jun 2026

Expires
19 Mar 2028

Reason
Other
MDR 753185 Supplemented

Technical documentation EU MDR

Issued
19 Jun 2026

Expires
19 Mar 2028

Reason
Other
MDR 719661 Supplemented

Technical documentation EU MDR

Issued
25 Aug 2026

Expires
7 Mar 2028

Reason
Other
MDR 719663 Supplemented

Technical documentation EU MDR

Issued
25 Aug 2026

Expires
18 Jan 2028

Reason
Other
MDR 721069 Supplemented

Quality management system EU MDR

Issued
29 Sep 2026

Expires
10 Jan 2028

Reason
Change approved
MDR 719649 Supplemented

Technical documentation EU MDR

Issued
5 Jun 2026

Expires
15 Dec 2027

Reason
Other

Authorised representatives

Notified bodies

Notified body 2797

FDA recalls105

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

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.

Showing the 10 most recent of 105 recalls.

2026
- 8 Sep 2026 Z-0153-2027 Not yet classified Ongoing Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
2025
- 15 Aug 2025 Z-2605-2025 Class II Ongoing Potential for barb non-engagement.
2024
- 20 Dec 2024 Z-1096-2025 Class II Ongoing 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.
- 20 Dec 2024 Z-1097-2025 Class II Ongoing 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.
- 20 Dec 2024 Z-1098-2025 Class II Ongoing 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.
- 8 Oct 2024 Z-0487-2025 Class II Ongoing Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
- 25 Sep 2024 Z-0319-2025 Class II Ongoing 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.
- 10 May 2024 Z-2144-2024 Class II Ongoing Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 10 May 2024 Z-2145-2024 Class II Ongoing Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 10 May 2024 Z-2146-2024 Class II Ongoing Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Show the 25 most recent of 105 recalls

2024
- 10 May 2024 Z-2147-2024 Class II Ongoing Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 10 May 2024 Z-2148-2024 Class II Ongoing Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 10 May 2024 Z-2149-2024 Class II Ongoing Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 23 Apr 2024 Z-1881-2024 Class II Ongoing Some applicator tips from these lots had open seals.
- 8 Mar 2024 Z-1533-2024 Class II Ongoing Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
2023
- 10 Aug 2023 Z-2616-2023 Class II Ongoing Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
- 10 Aug 2023 Z-2617-2023 Class II Ongoing Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
- 31 Mar 2023 Z-1571-2023 Class II Ongoing 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
2022
- 16 Nov 2022 Z-0480-2023 Class II Ongoing knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
- 20 Sep 2022 Z-0150-2023 Class II Ongoing Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
- 8 Aug 2022 Z-1773-2022 Class II Ongoing Product may contain the incorrect material which could impact treatment.
- 24 Mar 2022 Z-1053-2022 Class II Ongoing Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
2021
- 4 Jan 2021 Z-0953-2021 Class II Terminated Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
2020
- 23 Oct 2020 Z-0533-2021 Class II Terminated The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
- 9 Sep 2020 Z-0116-2021 Class II Terminated Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles

FDA establishments2

Registered with the FDA under this company group, matched by name.

Ethicon, Inc. Raritan, NJ · US FEI 3017102971
Ethicon, Inc. CIUDAD JUAREZ Chihuahua · MX FEI 3006638824

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
Email: [email protected]
Phone: +1(877)384-4266
PRRC contact: Linda Plews
EUDAMED SRN: US-MF-000013111
FDA FEI number: 3007791599
DUNS number: 002144145

Catalogue7,046

Prolene Ref F2804

Prolene Ref F2800

Prolene Ref MPP8604H

Prolene Ref W525

Perma-Hand Ref W888

Coated VICRYL Ref V465H

Mersilene Ref FB1728G

Virgin Silk Ref FV769

Prolene Ref EH7814E

Coated VICRYL Ref BV1389

Coated VICRYL Ref PA2671H

Coated VICRYL Ref JB9996G

Coated VICRYL Ref V524H

Prolene Ref W8816

Prolene Ref 8660H

Coated VICRYL Ref JC515H

Prolene Ref EH7472H

Coated VICRYL Ref MIC515H

Prolene Ref 8683H

Mersilene Ref F2536H

Perma-Hand Ref FK831

Prolene Ref NP0137

Prolene Ref EH7221H

Perma-Hand Ref FW333

Coated VICRYL Ref W9825

Coated VICRYL Ref MPV9526H

Coated VICRYL Ref V3060H

Coated VICRYL Ref J9762G

Prolene Ref EH7090H

Perma-Hand Ref K871H

Coated VICRYL Ref MIC582H

Ethilon Ref EH7276H

Prolene Ref 3DPM

Coated VICRYL Ref JV987

Coated VICRYL Ref 3JC2643H

Prolene Ref MD5642H

Prolene Ref BP527

Vicryl Ref V439G

Perma-Hand Ref W794

Coated VICRYL Ref V583G

Coated VICRYL Ref V278H

Prolene Ref W8844

Prolene Ref EH7692H

Perma-Hand Ref 640H

Perma-Hand Ref W196G

Perma-Hand Ref F736

Vicryl Ref W1702

Coated VICRYL Ref V491H

Prolene Ref D10094

Perma-Hand Ref W765