Category

Surgical Devices Recalls

3,817 surgical devices recalls on record from CPSC, FDA, and USDA.

3,817 recalls
High RiskFDA
Ra Medical Systems, Inc.
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser ...
Surgical Devices·5,082 affected·Sep 19, 2019
High RiskFDA
Icecure Medical Ltd
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extre...
Surgical Devices·16 affected·Sep 16, 2019
High RiskFDA
Becton Dickinson & Company
13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Cat...
Surgical Devices·75 affected·Sep 16, 2019
High RiskFDA
Stryker Corporation
Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 Th...
Surgical Devices·0 affected·Sep 12, 2019
High RiskFDA
Mizuho America, Inc.
Microsurgical Operating Room Tables;7300BX (18-351-70).
Surgical Devices·10 affected·Sep 11, 2019
High RiskFDA
Mizuho America, Inc.
Microsurgical Operating Room Tables;7300B (18-350-70);
Surgical Devices·8 affected·Sep 11, 2019
High RiskFDA
Candela Corporation
Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
Surgical Devices·7,560 affected·Sep 10, 2019
High RiskFDA
Candela Corporation
Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
Surgical Devices·386 affected·Sep 10, 2019
High RiskFDA
Medline Industries Inc
MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body...
Surgical Devices·500 affected·Sep 6, 2019
High RiskFDA
Medtronic Vascular Galway Dba Medtronic Ireland
Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC201...
Surgical Devices·98,675 affected·Sep 3, 2019
High RiskFDA
Respiratory Therapeutics Group Llc
RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Su...
Surgical Devices·723 affected·Aug 19, 2019
RecallFDA
Coopersurgical, Inc.
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
Surgical Devices·4,930 affected·Aug 19, 2019
High RiskFDA
Bard Peripheral Vascular Inc
Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommend...
Surgical Devices·286 affected·Aug 14, 2019
High RiskFDA
Arrow International Inc
8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACT...
Surgical Devices·520 affected·Aug 6, 2019
High RiskFDA
Arrow International Inc
Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous ...
Surgical Devices·231 affected·Aug 6, 2019
High RiskFDA
Stryker Communications
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light Sy...
Surgical Devices·52 affected·Aug 1, 2019
High RiskFDA
Rocket Medical Plc
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Surgical Devices·1,081 affected·Aug 1, 2019
High RiskFDA
Haag-streit Usa Inc
HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible ...
Surgical Devices·1 affected·Jul 31, 2019
High RiskFDA
Haag-streit Usa Inc
HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible thro...
Surgical Devices·0 affected·Jul 31, 2019
High RiskFDA
Haag-streit Usa Inc
HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible thro...
Surgical Devices·0 affected·Jul 31, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and acce...
Surgical Devices·52 affected·Jul 26, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and ac...
Surgical Devices·123 affected·Jul 26, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perf...
Surgical Devices·4 affected·Jul 26, 2019
High RiskFDA
Stryker Gmbh
Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a ...
Surgical Devices·35 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system ...
Surgical Devices·2,248 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system ...
Surgical Devices·251 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a ...
Surgical Devices·76 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF sys...
Surgical Devices·1,533 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EP...
Surgical Devices·110 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF sy...
Surgical Devices·259 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is ...
Surgical Devices·476 affected·Jul 25, 2019
High RiskFDA
Stryker Gmbh
Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system...
Surgical Devices·53 affected·Jul 25, 2019
High RiskFDA
Lemaitre Vascular, Inc.
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm...
Surgical Devices·62 affected·Jul 24, 2019
High RiskFDA
Integra Lifesciences Corp.
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neur...
Surgical Devices·125 affected·Jul 19, 2019
High RiskFDA
Arrow International Inc
Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Pr...
Surgical Devices·745 affected·Jul 18, 2019
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm...
Surgical Devices·4,654 affected·Jul 8, 2019
High RiskFDA
Intuitive Surgical, Inc.
daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are i...
Surgical Devices·0 affected·Jul 1, 2019
High RiskFDA
Intuitive Surgical, Inc.
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are ...
Surgical Devices·22,752 affected·Jul 1, 2019
High RiskFDA
Degania Silicone, Ltd.
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage cath...
Surgical Devices·6,960 affected·Jun 28, 2019
High RiskFDA
Degania Silicone, Ltd.
Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage cathe...
Surgical Devices·2,160 affected·Jun 28, 2019
High RiskFDA
Degania Silicone, Ltd.
Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flex...
Surgical Devices·640 affected·Jun 28, 2019
High RiskFDA
Degania Silicone, Ltd.
Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that...
Surgical Devices·2,700 affected·Jun 28, 2019
High RiskFDA
Degania Silicone, Ltd.
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage cath...
Surgical Devices·6,080 affected·Jun 28, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is int...
Surgical Devices·2 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS Sys...
Surgical Devices·240 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is inte...
Surgical Devices·3 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is inte...
Surgical Devices·4 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is inte...
Surgical Devices·3 affected·Jun 25, 2019