Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Intuitive Surgical, Inc.
STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Re...
Surgical Devices·2,065 affected·Jul 14, 2016
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Re...
Surgical Devices·875 affected·Jul 14, 2016
High RiskFDA
Intuitive Surgical, Inc.
STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument ...
Surgical Devices·875 affected·Jul 14, 2016
High RiskFDA
Accessclosure, Inc., A Cardinal Health Company
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated...
Surgical Devices·55 affected·Jul 13, 2016
High RiskFDA
C.r. Bard, Inc.
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Surgical Devices·274 affected·Jul 11, 2016
High RiskFDA
Bausch & Lomb Inc Irb
Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
Surgical Devices·384 affected·Jul 11, 2016
High RiskFDA
C.r. Bard, Inc.
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
Surgical Devices·274 affected·Jul 11, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes ar...
Surgical Devices·19,200 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The Valleylab Laparoscopic Handset and Electrodes are indicated f...
Surgical Devices·85,630 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab Laparoscopic Handset and Elec...
Surgical Devices·6,769 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab Laparoscopic Handset and Electrodes are indicated f...
Surgical Devices·24,870 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab Laparoscopic Handset and Electrodes are indicated f...
Surgical Devices·332 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and Electrodes are indicated f...
Surgical Devices·0 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are...
Surgical Devices·3,470 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are ...
Surgical Devices·50,055 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic Handset and Electrodes are i...
Surgical Devices·63,320 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and Electrodes are ...
Surgical Devices·13,420 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated...
Surgical Devices·6,381 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The Valleylab Laparoscopic Handset and Electrodes are indicated...
Surgical Devices·161,940 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab Laparoscopic Handset and Electrodes are indicated fo...
Surgical Devices·349,629 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparoscopic Handset and Electrodes ...
Surgical Devices·1,440 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicate...
Surgical Devices·0 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP The Valleylab Laparoscopic Handset and Electro...
Surgical Devices·0 affected·Jul 8, 2016
High RiskFDA
Medtronic
Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Valleylab Laparoscopic Handset and Electrodes are indicated fo...
Surgical Devices·42,900 affected·Jul 8, 2016
High RiskFDA
Arrow International Inc
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Surgical Devices·2,425 affected·Jul 7, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip syst...
Surgical Devices·241 affected·Jul 1, 2016
High RiskFDA
Sorin Group Usa, Inc.
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Can...
Surgical Devices·5,740 affected·Jun 22, 2016
High RiskFDA
Medtronic Navigation
PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgi...
Surgical Devices·52 affected·Jun 20, 2016
High RiskFDA
Walkmed Infusion, Llc
T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids...
Surgical Devices·58 affected·Jun 14, 2016
High RiskFDA
Walkmed Infusion, Llc
T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. ...
Surgical Devices·1,147 affected·Jun 14, 2016
High RiskFDA
Walkmed Infusion, Llc
T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to admin...
Surgical Devices·270 affected·Jun 14, 2016
High RiskFDA
Walkmed Infusion, Llc
T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from...
Surgical Devices·2,757 affected·Jun 14, 2016
High RiskFDA
Walkmed Infusion, Llc
T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per ...
Surgical Devices·2,198 affected·Jun 14, 2016
High RiskFDA
Walkmed Infusion, Llc
T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer...
Surgical Devices·383 affected·Jun 14, 2016
High RiskFDA
Walkmed Infusion, Llc
T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer ...
Surgical Devices·295 affected·Jun 14, 2016
High RiskFDA
Walkmed Infusion, Llc
T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Produ...
Surgical Devices·7,529 affected·Jun 14, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Conven...
Surgical Devices·48 affected·Jun 8, 2016
High RiskFDA
Synthes (usa) Products Llc
Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017...
Surgical Devices·2,064 affected·Jun 7, 2016
High RiskFDA
Arrow International Inc
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-ter...
Surgical Devices·1 affected·Jun 2, 2016
High RiskFDA
Arrow International Inc
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material A...
Surgical Devices·50 affected·Jun 2, 2016
High RiskFDA
Arrow International Inc
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material A...
Surgical Devices·50 affected·Jun 2, 2016
CriticalFDA
Conmed Corporation
Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used fo...
Surgical Devices·307,684 affected·May 18, 2016
CriticalFDA
Conmed Corporation
Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be us...
Surgical Devices·6,640 affected·May 18, 2016
CriticalFDA
Conmed Corporation
Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dis...
Surgical Devices·4,480 affected·May 18, 2016
CriticalFDA
Conmed Corporation
Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 640...
Surgical Devices·124,333 affected·May 18, 2016
High RiskFDA
Datascope Corporation
MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with In...
Surgical Devices·31,030 affected·May 13, 2016
High RiskFDA
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Sa...
Surgical Devices·368 affected·May 13, 2016
High RiskFDA
Baxter Healthcare Corp
COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechani...
Surgical Devices·6,804 affected·May 12, 2016