The Recall Desk

Manufacturer

Ethicon, Inc.

70 recalls in our database name Ethicon, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
70
Critical
0
Severe
3
Most recent
2024-11-27

Of the 70 recalls from Ethicon, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 70

  • HighFDA (Devices)·Z-0487-2025·2024-11-27

    Ethicon Recalls Monocryl Sutures Due to Component Mix-Up

    Ethicon, Inc. is recalling 16,524 units of Monocryl sutures because a manufacturing error may result in incorrect needle types, sizes, or suture lengths.

    Product
    MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0319-2025·2024-11-13

    Coated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation

    Ethicon is recalling Coated VICRYL surgical sutures due to needle pull-off and visual degradation. Lot QP2AJM, consisting of 31,032 units, was distributed to China.

    Product
    Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2144-2024·2024-06-26

    VICRYL Sutures recalled due to packaging defect compromising sterility

    Ethicon recalls 341,532 units of VICRYL surgical sutures worldwide due to holes in primary packaging that compromise sterility and could result in infection.

    Product
    VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2024·2024-06-26

    MONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect

    Ethicon recalls 306,000 MONOCRYL surgical sutures worldwide due to holes in primary packaging from a manufacturing defect that compromises sterility and could result in infection.

    Product
    MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2024·2024-06-26

    PDS II Polydioxanone Sutures Recalled Due to Compromised Sterility

    Ethicon is recalling 56,952 units of PDS II polydioxanone sutures distributed worldwide because a packaging defect resulted in compromised sterility, which could lead to infection. No illnesses have been reported.

    Product
    PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2024·2024-06-26

    Ethicon MONOCRYL Plus Sutures Recalled for Packaging Defect

    Ethicon recalled 287,892 MONOCRYL Plus Antibacterial Sutures worldwide due to a packaging machine defect that created holes in primary packaging, potentially compromising sterility and risking infection.

    Product
    MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2024·2024-06-26

    FDA Recalls VICRYL Plus Antibacterial Sutures Due to Packaging Defect

    Ethicon is recalling VICRYL Plus Antibacterial Sutures due to a packaging machine defect that created holes in the primary packaging, potentially compromising product sterility. Affected sutures may pose an infection risk.

    Product
    VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB94
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2024·2024-06-26

    PDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility

    Ethicon recalls PDS Plus Antibacterial sutures due to packaging defects that compromised sterility. The affected units may cause infection if used in surgery.

    Product
    PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2024·2024-05-29

    SURGIFOAM Absorbable Gelatin Powder Kit Recalled for Open Applicator Tip Seals

    Ethicon recalls SURGIFOAM Absorbable Gelatin Powder Kit (Product Code 1979) due to open seals on applicator tips in three lots. The recall affects 5,184 units distributed nationwide.

    Product
    SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2024·2024-04-24

    Surgical Sutures Recalled for Sterility Compromise During Transit

    Ethicon recalls 395 units of STRATAFIX surgical sutures (lot SHBAEC) due to sterility compromise from environmental exposure during transit and storage. Product is unsuitable for surgical use.

    Product
    STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1571-2023·2023-05-17

    PDS Plus Antibacterial Suture Potential Breakage During Intraoperative Use

    Ethicon recalled 1,656 units of PDS Plus Antibacterial Suture due to potential breakage during surgery, which could compromise tissue approximation. The affected lot was distributed to the United Kingdom, Ireland, and Turkey.

    Product
    PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0480-2023·2022-12-21

    Ethicon PDS II Surgical Sutures Recalled for Deficient Knot Strength

    Ethicon recalls PDS II violet monofilament sutures due to significantly reduced knot tensile strength, posing risk of intra-operative breakage in surgical procedures. The affected lot was distributed internationally to Canada, Japan, Australia, and New Zealand.

    Product
    PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0150-2023·2022-11-09

    STRATAFIX Absorbable Sutures Recalled for Wrong Needle Type

    Ethicon recalls STRATAFIX absorbable sutures after discovering some packages contain the wrong needle type. The PS-1 cutting edge needle instead of the intended SH taper point needle may cause more tissue trauma than anticipated.

    Product
    STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1773-2022·2022-09-28

    Ethicon PDS II Surgical Sutures Recalled for Incorrect Material

    Ethicon recalls PDS II surgical sutures distributed in Japan due to potential incorrect material composition that could affect treatment outcomes. No injuries have been reported.

    Product
    PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1053-2022·2022-05-18

    Ethicon STRATAFIX Surgical Sutures Recalled for Incorrect Needle Type and Size

    Ethicon is recalling STRATAFIX surgical sutures (lots AAHM529 and AAHQ049) due to component mix-ups resulting in incorrect needle types, sizes, or suture lengths. 2,808 units distributed internationally are affected.

    Product
    STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0953-2021·2021-02-10

    Ethicon Dermabond Advanced Topical Skin Adhesive Recalled for Sterility Breach Risk

    Ethicon is recalling Dermabond Advanced Topical Skin Adhesive because red tape in the packaging could compromise the sterile seal, potentially leading to a sterility breach.

    Product
    Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0116-2021·2020-10-28

    Ethicon Recalls VICRYL Sutures Due to Packaging Mismatch

    Ethicon is recalling VICRYL sutures because the foil package may not match the label and carton. The incorrect suture differs in size, length, and construction.

    Product
    VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2486-2020·2020-07-08

    Ethicon Recalls Silk Sutures Due to Potential Shelf Life Deficiency

    Ethicon, Inc. is recalling specific lots of PERMA-HAND/MERSILK and VIRGIN SILK Blue twisted Silk Sutures because they may not meet the required 5-year shelf life.

    Product
    PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1334-2020·2020-02-26

    Ethicon Recalls Three Stratafix Suture Units for Internal Testing Failures

    Ethicon, Inc. is recalling three units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.

    Product
    1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1335-2020·2020-02-26

    Ethicon Recalls Stratafix Spiral Sutures Due to Testing Failures

    Ethicon, Inc. is recalling 660 units of Stratafix Spiral PDS Plus Violet sutures because the product did not meet internal testing specifications.

    Product
    1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1336-2020·2020-02-26

    Ethicon Recalls Stratafix Spiral Sutures for Internal Testing Failures

    Ethicon, Inc. is recalling 133 units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.

    Product
    1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0989-2020·2020-02-12

    Ethicon Recalls VICRYL Sutures Due to Braid Fraying

    Ethicon is recalling specific VICRYL sutures because braid fraying may reduce tensile strength. The recall covers 23,688 units distributed in the US and Puerto Rico.

    Product
    Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0048-2020·2019-10-16

    Ethicon Recalls STRATAFIX Spiral Sutures Due to Strength Testing Failures

    Ethicon, Inc. is recalling 852 units of STRATAFIX Spiral PDS Plus Violet 27 sutures because they do not meet internal strength testing specifications.

    Product
    STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0047-2020·2019-10-16

    Ethicon Recalls STRATAFIX Spiral PDS Plus Violet Sutures

    Ethicon, Inc. is recalling 416 units of STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle sutures because the product does not meet internal strength testing specifications.

    Product
    STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
    Category
    Medical Device
    Distribution
    18 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Ethicon Inc.

pharmaceutical company

Country
United States
Founded
1930
Parent company
Johnson & Johnson

Official website

Source: Wikidata (Q3733763), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.