PlainRecalls

Ethicon, Inc.

47 recalls on record · Latest: Nov 13, 2024

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 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 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 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 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 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 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 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 May 2, 2018

Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Applicat…

FDA Devices Moderate Apr 18, 2018

PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle

FDA Devices Moderate Apr 18, 2018

PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle

FDA Devices Moderate Mar 28, 2018

DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily ap…

FDA Devices Moderate Mar 7, 2018

Coated VICRYL RAPIDETM (Polyglactin 910) Suture

FDA Devices Moderate Oct 5, 2016

ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)

FDA Devices Moderate Jun 22, 2016

EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to …

FDA Devices Moderate Jan 13, 2016

Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a th…

FDA Devices Moderate Jul 1, 2015

Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #…

FDA Devices Moderate Dec 10, 2014

Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.

FDA Devices Moderate Dec 18, 2013

Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue appr…

FDA Devices Critical Nov 28, 2012

ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 S…

FDA Devices Critical Nov 28, 2012

ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorb…

FDA Devices Moderate Oct 31, 2012

EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat O…