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Ethicon Inc.

Active in EUDAMED

Registered as Ethicon, LLC. in EUDAMED

Also registered as ETHICON, LLC, Ethicon GmbH

United Statesfrom SRN EUDAMED FDA SRN US-MF-000013111 FEI 3007791599

Ethicon Inc. is a medical device manufacturer based in the United States, with 8,127 devices listed and 106 FDA recalls as of 13 Nov 2026.

Devices
8,127
Registrations
EUDAMEDFDA
FDA recalls
10623 ongoing since 2021 (26 open in total)
3 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 2,406
  • FDA GUDID 1,504
  • FDA 510(k) 3

Among the 3,000 best-ranked of 8,127 devices.

Device classes
  • EU Class III 1,470
  • FDA Class II 1,394
  • EU Class IIa 77
  • EU Class IIb 32
  • FDA Class I 10
  • EU Class I 9

Among the 3,000 best-ranked of 8,127 devices.

Top EMDN categories

Among the 3,000 best-ranked of 8,127 devices.

FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000013111
  • FDA FEI 3007791599
  • DUNS 002144145

At a glance

Counted by deviCERTS from registry records

EU certificates

20 of 20 in force.

See certificates

Market reach

European Union
EUDAMED actor, 20 certificates
United States
FDA establishment, FDA recalls
Authorised rep.
Johnson & Johnson Medical GmbHDE
Authorised rep.
Johnson & Johnson Medical GmbHDE

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8,127

Newest first, rows 1-50 of 8,127

Search and filter all 8,127 devices
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  • Stratafix SXPN1B402

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B413

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B409

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B403

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B404

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B412

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN2B400

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B401

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B400

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B410

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B411

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B408

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN2B402

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B405

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B406

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN2B403

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN1B407

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN2B404

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN2B405

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Stratafix SXPN2B406

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Pds Ii Ref W9860H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref FZ1023H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z3060H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z626E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z4630H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pronova Ref PN8529H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z636H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vicryl Rapide Ref W9940

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vicryl Rapide Ref VR2299

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vicryl Rapide Ref MPVR9913H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref PS2926G

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref W9235T

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z620E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z636E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref W9108H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z170H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z497H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vicryl Rapide Ref VR2238

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z500E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pronova Ref PN8809LG

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pronova Ref PN1852H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref JG2942H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z9967T

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref PN2997E

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref ZT2924SG

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z997H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vicryl Rapide Ref FH1642H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref W9950T

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Pds Ii Ref Z3150BG

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Vicryl Rapide Ref VRI215H

    Active Regimes: CE MDR Registry: EUDAMED Class:III

Rows 1-50 of 8,127

Showing 1-50 of 8,127

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000013111
FDA FEI number
3007791599
DUNS number
002144145
EUDAMED status
Active
EUDAMED registered name
Ethicon, LLC.
Registered address
475 C Street, 00969, Guaynabo, Puerto Rico, United States
Phone
+1(877)384-4266
PRRC contact
Marjorie Medina(public in EUDAMED)
2 more people
  • Jenniffer Ruiz Tubens
  • Linda Plews

EUDAMED certificates20

20 certificates20 valid, 0 expiredMDR 20next expiry 15 Dec 2027

EUDAMED certificates (20)

BSI Group The Netherlands B.V. 2797 20 certificates

  • MDR 719610 Active Reissued

    Quality management system EU MDR

    Issued
    4 Sep 2026
    Expires
    13 Oct 2031
    Valid from
    14 Oct 2026
  • MDR 753200 Active Reissued

    Technical documentation EU MDR

    Issued
    9 Sep 2026
    Expires
    8 Sep 2031
  • MDR 753183 Active Reissued

    Technical documentation EU MDR

    Issued
    22 Dec 2025
    Expires
    9 Dec 2030
  • MDR 721298 Active

    Technical documentation EU MDR

    Issued
    4 Dec 2023
    Expires
    3 Dec 2028
  • MDR 719659 Active Supplemented

    Technical documentation EU MDR

    Issued
    14 May 2026
    Expires
    19 Oct 2028
    Reason
    Change approved
  • MDR 719656 Active Supplemented

    Technical documentation EU MDR

    Issued
    15 Apr 2025
    Expires
    12 Oct 2028
    Reason
    Change approved
  • MDR 719670 Active Amended

    Technical documentation EU MDR

    Issued
    19 Aug 2024
    Expires
    12 Oct 2028
    Reason
    Other
  • MDR 753191 Active Supplemented

    Technical documentation EU MDR

    Issued
    19 Jun 2026
    Expires
    19 Jul 2028
    Reason
    Other
  • MDR 753195 Active Amended

    Technical documentation EU MDR

    Issued
    25 Aug 2025
    Expires
    19 Jul 2028
    Reason
    Other
  • MDR 753197 Active Supplemented

    Technical documentation EU MDR

    Issued
    19 Jun 2026
    Expires
    19 Jul 2028
    Reason
    Other
  • MDR 719650 Active Supplemented

    Technical documentation EU MDR

    Issued
    5 Jun 2026
    Expires
    4 Jul 2028
    Reason
    Other
  • MDR 719658 Active Supplemented

    Technical documentation EU MDR

    Issued
    5 Jun 2026
    Expires
    4 Jul 2028
    Reason
    Other
  • MDR 753179 Active Amended

    Technical documentation EU MDR

    Issued
    22 Apr 2026
    Expires
    19 Mar 2028
    Reason
    Other
  • MDR 753181 Active Supplemented

    Technical documentation EU MDR

    Issued
    19 Jun 2026
    Expires
    19 Mar 2028
    Reason
    Other
  • MDR 753185 Active Supplemented

    Technical documentation EU MDR

    Issued
    19 Jun 2026
    Expires
    19 Mar 2028
    Reason
    Other
  • MDR 719661 Active Supplemented

    Technical documentation EU MDR

    Issued
    25 Aug 2026
    Expires
    7 Mar 2028
    Reason
    Other
  • MDR 719663 Active Supplemented

    Technical documentation EU MDR

    Issued
    25 Aug 2026
    Expires
    18 Jan 2028
    Reason
    Other
  • MDR 721069 Active Supplemented

    Quality management system EU MDR

    Issued
    29 Sep 2026
    Expires
    10 Jan 2028
    Reason
    Change approved
  • MDR 719649 Active Supplemented

    Technical documentation EU MDR

    Issued
    5 Jun 2026
    Expires
    15 Dec 2027
    Reason
    Other
  • MDR 719664 Active Amended

    Technical documentation EU MDR

    Issued
    19 Aug 2024
    Expires
    15 Dec 2027
    Reason
    Other

FDA recalls106

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 105 recalls initiated by Ethicon Inc., the earliest on 2004-12-16 and the most recent on 2026-09-08. By recorded status: 25 ongoing and 80 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 2
  • 2018 27
  • 2019 10
  • 2020 4
  • 2021 1
  • 2022 4
  • 2023 3
  • 2024 13
  • 2025 1
  • 2026 2

39 initiated before 2017

Showing the 10 most recent of 106 recalls.

  • 2026

    • 23 Sep 2026 Z-0284-2027 Not yet classified Ongoing Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively. Distribution: International distribution to the countries of JP, CA, AU. Submission number: K946173
    • 8 Sep 2026 Z-0153-2027 Class II 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. Distribution: Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK,…
      Full distribution text Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.
      Submission number: K946173

  • 2025

    • 15 Aug 2025 Z-2605-2025 Class II Ongoing Potential for barb non-engagement. Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA,…
      Full distribution text Worldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI and the countries of Singapore and Malaysia.
      Submission number: K192144

  • 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. Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.
      Submission number: K133356
    • 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. Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.
      Submission number: K946173
    • 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. Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.
    • 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. Distribution: U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,…
      Full distribution text U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Not provided.
      Submission number: K964072
    • 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. Distribution: International distribution to the country of China. Submission number: K183183
    • 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 . Distribution: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC,…
      Full distribution text Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
      Submission number: K022269
    • 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 . Distribution: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC,…
      Full distribution text Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
      Submission number: K181652
Show the 25 most recent of 106 recalls

  • 2024

    • 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 . Distribution: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC,…
      Full distribution text Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
      Submission number: K183183
    • 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 . Distribution: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC,…
      Full distribution text Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
      Submission numbers: K212380, K061037
    • 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 . Distribution: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC,…
      Full distribution text Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
      Submission numbers: K960653, K964072
    • 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 . Distribution: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC,…
      Full distribution text Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
      Submission number: K201996
    • 23 Apr 2024 Z-1881-2024 Class II Ongoing Some applicator tips from these lots had open seals. Distribution: US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY, MA, MD, MN, MO, NC, NE, NJ, PA, TN, TX, WI. Submission number: P990004
    • 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 Distribution: CO GA IA MI NJ NY NY PA SC WI Submission number: K192580

  • 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. Distribution: US Nationwide. Global Distribution.
    • 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. Distribution: US Nationwide. Global Distribution.
    • 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 Distribution: International distribution in the countries of United Kingdom, Ireland and Turkey. Submission number: K061037

  • 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 Distribution: International (OUS) only: Canada, Japan, Australia and New Zealand
    • 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 Distribution: International distribution of the country of China. Submission number: K151200
    • 8 Aug 2022 Z-1773-2022 Class II Ongoing Product may contain the incorrect material which could impact treatment. Distribution: Distribution in Japan only
    • 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. Distribution: International distribution in the country of China. Submission number: K122898

  • 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 Distribution: US Nationwide Submission numbers: K100423, K152096

  • 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. Distribution: The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only…
      Full distribution text The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only recalling the 15 units that were distributed in South Korea due to South Korea's Ministry of Food and Drug Safety (MFDS) requirements.
      Submission number: K060713

Sites1

FDA establishments1

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

  • Ethicon, Inc. CIUDAD JUAREZ Chihuahua · MX FEI 3006638824

Frequently asked questions

How many devices does Ethicon Inc. have in the registry?

The registry currently lists 8127 devices for Ethicon Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ethicon Inc.'s devices?

Among its 50 most recently registered devices, Ethicon Inc. has devices listed in EUDAMED (30 devices) and FDA GUDID (20 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Ethicon Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Ethicon Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Ethicon Inc.?

FDA recall records list 106 recalls initiated by Ethicon Inc., the most recent initiated on 23 Sep 2026. 26 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Ethicon Inc.?

EUDAMED lists 20 certificates for Ethicon Inc. (quality management system; technical documentation) under MDR. 1 is recorded with the status issued. The most recent was issued on 29 Sep 2026.

What are the newest devices from Ethicon Inc. in the registry?

The most recently registered devices listed for Ethicon Inc. include STRATAFIX SXPN1B402, STRATAFIX SXPN1B413, STRATAFIX SXPN1B409 and STRATAFIX SXPN1B403.

Generated automatically from registry data and not verified by a human reviewer.