Brand
Ethicon, Inc. Recalls
44 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Ethicon, Inc..
44Total Recalls
2Critical
2.3MUnits Affected
Sep 25, 2024Most Recent
All Recalls
Every Ethicon, Inc. Recall
Sorted by most recent. Click any recall for full details.
44 recalls
High RiskFDA
Ethicon, Inc.
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Medical Devices31,032 affectedSep 25, 2024
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardio...
Medical Devices45,828 affectedMay 10, 2024
High RiskFDA
Ethicon, Inc.
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material ...
Medical Devices306,000 affectedMay 10, 2024
High RiskFDA
Ethicon, Inc.
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic sur...
Medical Devices341,532 affectedMay 10, 2024
High RiskFDA
Ethicon, Inc.
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue,...
Medical Devices56,952 affectedMay 10, 2024
High RiskFDA
Ethicon, Inc.
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for o...
Medical Devices55,296 affectedMay 10, 2024
High RiskFDA
Ethicon, Inc.
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tis...
Medical Devices1,656 affectedMar 31, 2023
High RiskFDA
Ethicon, Inc.
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Medical Devices88 affectedAug 8, 2022
High RiskFDA
Ethicon, Inc.
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...
Medical Devices2,808 affectedMar 24, 2022
High RiskFDA
Ethicon, Inc.
Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgi...
Surgical Devices23,580 affectedJan 4, 2021
High RiskFDA
Ethicon, Inc.
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approxima...
Medical Devices1,032 affectedSep 9, 2020
High RiskFDA
Ethicon, Inc.
PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W181...
Medical Devices99,612 affectedJun 10, 2020
High RiskFDA
Ethicon, Inc.
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Surgical Devices23,688 affectedJan 3, 2020
High RiskFDA
Ethicon, Inc.
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
Medical Devices3 affectedAug 28, 2019
High RiskFDA
Ethicon, Inc.
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Medical Devices852 affectedAug 13, 2019
High RiskFDA
Ethicon, Inc.
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Sutur...
Medical Devices1,296 affectedApr 19, 2019
High RiskFDA
Ethicon, Inc.
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in ped...
Medical Devices550,681 affectedMar 12, 2019
High RiskFDA
Ethicon, Inc.
PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indi...
Medical Devices840 affectedDec 18, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 1070503120...
Medical Devices756 affectedJun 8, 2018
High RiskFDA
Ethicon, Inc.
PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705...
Medical Devices72 affectedJun 8, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G...
Medical Devices4,992 affectedJun 8, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
Medical Devices1,752 affectedMay 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
Medical Devices372 affectedMay 7, 2018
High RiskFDA
Ethicon, Inc.
PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
Medical Devices144 affectedMay 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
Medical Devices1,020 affectedMay 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
Medical Devices432 affectedMay 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
Medical Devices456 affectedMay 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
Medical Devices276 affectedMay 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
Medical Devices15,180 affectedMay 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
Medical Devices4,452 affectedMay 7, 2018
High RiskFDA
Ethicon, Inc.
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Hum...
Medical Devices738 affectedMar 7, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Medical Devices7,020 affectedJan 10, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
Medical Devices180 affectedJan 10, 2018
High RiskFDA
Ethicon, Inc.
DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold clos...
Surgical Devices20,090 affectedNov 27, 2017
High RiskFDA
Ethicon, Inc.
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Medical Devices129,372 affectedAug 17, 2017
High RiskFDA
Ethicon, Inc.
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Medical Devices396,024 affectedAug 1, 2016
High RiskFDA
Ethicon, Inc.
EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an...
Surgical Devices228 affectedApr 11, 2016
High RiskFDA
Ethicon, Inc.
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) Sy...
Medical Devices96,124 affectedDec 3, 2015
High RiskFDA
Ethicon, Inc.
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cu...
Surgical Devices1,922 affectedMay 8, 2015
High RiskFDA
Ethicon, Inc.
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Medical Devices2,508 affectedOct 17, 2014
High RiskFDA
Ethicon, Inc.
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft...
Medical Devices37,164 affectedSep 25, 2013
CriticalFDA
Ethicon, Inc.
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref...
Surgical Devices28,276 affectedAug 21, 2012
CriticalFDA
Ethicon, Inc.
ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a to...
Surgical Devices45,200 affectedAug 21, 2012
High RiskFDA
Ethicon, Inc.
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 8...
Medical Devices4,800 affectedJul 2, 2012