PlainRecalls

Ethicon, Inc.

Compiled from official public sources by the editorial team.

70 recalls on record · Latest: Nov 27, 2024

Ethicon, Inc. Recall Insight

Ethicon, Inc. appears on 70 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.069% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Nov 27, 2024, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Jul 25, 2018 to Nov 27, 2024.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Nov 27, 2024

MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but n…

FDA Devices Moderate Nov 13, 2024

Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

FDA Devices Moderate Jun 26, 2024

PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tis…

FDA Devices Moderate Jun 26, 2024

MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated…

FDA Devices Moderate Jun 26, 2024

VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but no…

FDA Devices Moderate Jun 26, 2024

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsur…

FDA Devices Moderate Jun 26, 2024

VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, c…

FDA Devices Moderate Jun 26, 2024

MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable ma…

FDA Devices Moderate May 29, 2024

SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

FDA Devices Moderate Apr 24, 2024

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 …

FDA Devices Moderate May 17, 2023

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 approxim…

FDA Devices Moderate Dec 21, 2022

PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in ped…

FDA Devices Moderate Nov 9, 2022

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 appropr…

FDA Devices Moderate Sep 28, 2022

PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles

FDA Devices Moderate May 18, 2022

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-…

FDA Devices Moderate Feb 10, 2021

Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incision…

FDA Devices Moderate Dec 9, 2020

PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

FDA Devices Moderate Oct 28, 2020

VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligatio…

FDA Devices Moderate Jul 8, 2020

PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W8…

FDA Devices Moderate Feb 26, 2020

1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201

FDA Devices Moderate Feb 26, 2020

1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402

FDA Devices Moderate Feb 26, 2020

1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429

FDA Devices Moderate Feb 12, 2020

Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.

FDA Devices Moderate Oct 16, 2019

STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture

FDA Devices Moderate Oct 16, 2019

STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture

FDA Devices Moderate Jun 26, 2019

ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intende…

FDA Devices Moderate Jun 26, 2019

ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended …

FDA Devices Moderate Apr 24, 2019

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 cardi…

FDA Devices Moderate Apr 24, 2019

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 SUT…

FDA Devices Moderate Apr 24, 2019

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 VICRY…

FDA Devices Moderate Jan 23, 2019

PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for us…

FDA Devices Moderate Aug 1, 2018

PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)

FDA Devices Moderate Aug 1, 2018

PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)

FDA Devices Moderate Aug 1, 2018

PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705…

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

FDA Devices Moderate Jul 25, 2018

PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

FDA Devices Moderate Jul 25, 2018

PRONOVA SUTURE BLUE 122CM M1.5, D10189

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.