Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Arrow International Inc
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
Surgical Devices·250 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow Central Venous Catheterization Kit ASK-04200-UPM
Surgical Devices·140 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
Surgical Devices·410 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
Surgical Devices·0 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow EPIDURAL CATHETERIZATION KIT YC-02220
Surgical Devices·160 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
Surgical Devices·540 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
Surgical Devices·205 affected·Dec 20, 2019
High RiskFDA
Arrow International Inc
Arrow EPIDURAL CATHETERIZATION KIT CK-02220
Surgical Devices·1,360 affected·Dec 20, 2019
High RiskFDA
Smith & Nephew, Inc.
LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 7143441...
Surgical Devices·59 affected·Dec 16, 2019
High RiskFDA
Coopersurgical, Inc.
ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product...
Surgical Devices·460 affected·Dec 13, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESS...
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION T...
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRA...
Surgical Devices·1,986 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION...
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Abbott Medical
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers a...
Surgical Devices·380 affected·Dec 9, 2019
High RiskFDA
Medtronic Navigation, Inc.
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Surgical Devices·177 affected·Dec 5, 2019
High RiskFDA
Degania Silicone, Ltd.
Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary outp...
Surgical Devices·2,080 affected·Dec 2, 2019
High RiskFDA
Datascope Corporation
Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET I...
Surgical Devices·523 affected·Nov 20, 2019
CriticalFDA
Arrow International Inc
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Surgical Devices·1 affected·Nov 15, 2019
CriticalFDA
Arrow International Inc
Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
Surgical Devices·71 affected·Nov 15, 2019
CriticalFDA
Cook Inc.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
Surgical Devices·6 affected·Nov 8, 2019
CriticalFDA
Cook Inc.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
Surgical Devices·58 affected·Nov 8, 2019
High RiskFDA
Boston Scientific Corporation
AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-...
Surgical Devices·169 affected·Nov 8, 2019
CriticalFDA
Cook Inc.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
Surgical Devices·43 affected·Nov 8, 2019
CriticalFDA
Cook Inc.
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
Surgical Devices·20 affected·Nov 8, 2019
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5...
Surgical Devices·16,380 affected·Nov 6, 2019
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number...
Surgical Devices·16,380 affected·Nov 6, 2019
High RiskFDA
Zimmer Biomet, Inc.
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
Surgical Devices·26 affected·Oct 25, 2019
CriticalFDA
Applied Medical Resources Corp
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)0060791511...
Surgical Devices·28,799 affected·Oct 24, 2019
High RiskFDA
Boston Scientific Corporation
NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7...
Surgical Devices·14,145 affected·Oct 24, 2019
High RiskFDA
Boston Scientific Corporation
Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H749393351...
Surgical Devices·14,145 affected·Oct 24, 2019
High RiskFDA
Encore Medical, Lp
EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product...
Surgical Devices·86 affected·Oct 22, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·30 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·10 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·5 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·10 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·30 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·5 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·425 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·5 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·145 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·80 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·791 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·740 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·35 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·1,679 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·405 affected·Oct 21, 2019