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.

26–50 of 70

  • SevereFDA (Devices)·Z-1841-2019·2019-06-26

    Ethicon Recalls Polyester Sutures Due to Potential High Endotoxin Levels

    Ethicon, Inc. is recalling specific lots of ETHIBOND EXCEL polyester sutures because raw materials may contain high endotoxin levels.

    Product
    ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2019·2019-06-26

    Ethicon Recalls Ethibond Excel Polyester Sutures Due to Endotoxin Risk

    Ethicon, Inc. is recalling specific lots of Ethibond Excel polyester sutures because raw materials used in manufacturing may contain high endotoxin levels.

    Product
    ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1135-2019·2019-04-24

    Ethicon Recalls VICRYL Plus Sutures Due to Labeling Mismatches

    Ethicon, Inc. is recalling VICRYL Plus Sutures because the product may not match the sales unit carton and foil label.

    Product
    VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SUTURE 18"(45CM) 1 VIO VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO VICRYL PLUS SUTURE 27"(70CM) 3-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1134-2019·2019-04-24

    Ethicon Recalls VICRYL Sutures Due to Labeling Mismatch

    Ethicon, Inc. is recalling VICRYL, VICRYL Plus, and PDS sutures because the product may not match the sales unit carton and foil label.

    Product
    VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1136-2019·2019-04-24

    Ethicon Recalls VICRYL and PDS Sutures Due to Labeling Mismatches

    Ethicon, Inc. is recalling VICRYL, VICRYL Plus, and PDS sutures because the product inside may not match the sales unit carton and foil label.

    Product
    PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0747-2019·2019-01-23

    Ethicon Recalls PERMA-HAND Silk Sutures Due to Labeling Mismatch

    Ethicon is recalling 840 units of PERMA-HAND Silk Sutures because the product inside the packaging does not match the size or type indicated on the label.

    Product
    PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2532-2018·2018-08-01

    Ethicon Recalls PDS Plus Antibacterial Sutures Due to Tensile Strength Defect

    Ethicon, Inc. is recalling specific lots of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications.

    Product
    PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2533-2018·2018-08-01

    Ethicon Recalls PDS Plus Antibacterial Sutures for Tensile Strength Defects

    Ethicon, Inc. is recalling 756 units of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications. The affected products were distributed in Japan.

    Product
    PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2534-2018·2018-08-01

    Ethicon Recalls PDS II Sutures for Tensile Strength Deficiency

    Ethicon, Inc. is recalling 72 units of PDS II sutures because they do not meet tensile strength specifications.

    Product
    PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2464-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling 372 units of Proline Suture Blue 18" 7-0 because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.

    Product
    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2456-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling 300 units of Proline Suture 30" 6-0 Blue because a packaging design issue may allow the needle to perforate the package, posing injury or infection risks.

    Product
    PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2465-2018·2018-07-25

    Ethicon Recalls PRONOVA Suture Needles Due to Packaging Perforation Risk

    Ethicon is recalling specific PRONOVA suture needles because a packaging design issue may allow the needle to perforate the package, posing injury or infection risks.

    Product
    PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2463-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Proline suture products because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.

    Product
    PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2448-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Proline suture products because a packaging design issue allows needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2455-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue

    Ethicon, Inc. is recalling 432 units of Prolene Suture 30" 8-0 Blue (D8292) because the needle may perforate the packaging, posing a risk of injury or infection.

    Product
    PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2453-2018·2018-07-25

    Ethicon Prolene Suture Recall Due to Packaging Perforation Risk

    Ethicon is recalling specific Prolene suture products because a packaging design issue may allow needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2450-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue

    Ethicon is recalling specific Prolene suture products because a packaging design issue allows needles to perforate the package, posing a risk of injury or infection.

    Product
    PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2462-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Prolene suture products because a packaging design issue allows needles to perforate the package, posing risks of soft tissue injury or infection.

    Product
    PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2452-2018·2018-07-25

    Ethicon Recalls Certain Proline Sutures Due to Packaging Design Issue

    Ethicon is recalling specific Proline sutures because a packaging design issue allows the needle to perforate the package, posing a risk of injury or infection.

    Product
    PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2454-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling 588 units of Proline Suture Blue 4x18" 5/0 due to a packaging design issue that may allow the needle to perforate the package, posing a risk of injury or infection.

    Product
    PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2449-2018·2018-07-25

    Ethicon Proline Suture Recall Due to Packaging Perforation Risk

    Ethicon is recalling 1,728 units of Proline suture because a packaging design issue allows needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2451-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue

    Ethicon, Inc. is recalling specific Prolene suture products because a packaging design issue allows the needle to perforate the package, posing a risk of injury or infection.

    Product
    PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2457-2018·2018-07-25

    Ethicon Recalls Prolene Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Prolene suture units because a packaging design issue allows needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2466-2018·2018-07-25

    Ethicon Recalls Pronova Suture Due to Packaging Perforation Risk

    Ethicon is recalling 516 units of Pronova Suture Blue because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.

    Product
    PRONOVA SUTURE BLUE 122CM M1.5, D10189
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2461-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Prolene suture products because a packaging design issue may allow needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
    Category
    Medical Device
    Distribution
    25 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.