Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Synthes (usa) Products Llc
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in ...
Surgical Devices·198 affected·Oct 31, 2016
High RiskFDA
Spectranetics Corporation
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 Th...
Surgical Devices·14,624 affected·Oct 31, 2016
High RiskFDA
Integra York Pa, Inc
Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surg...
Surgical Devices·150 affected·Oct 28, 2016
High RiskFDA
Integra York Pa, Inc
Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended...
Surgical Devices·50 affected·Oct 28, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavi...
Surgical Devices·2,172 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the...
Surgical Devices·5,055 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the ...
Surgical Devices·4,836 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the c...
Surgical Devices·1,617 affected·Oct 26, 2016
CriticalFDA
Centurion Medical Products Corporation
Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring a...
Surgical Devices·1,000 affected·Oct 21, 2016
High RiskFDA
Micromedics, Inc.
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Surgical Devices·273 affected·Oct 20, 2016
High RiskFDA
Bausch & Lomb, Inc.
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of...
Surgical Devices·2,487 affected·Oct 12, 2016
High RiskFDA
C.r. Bard, Inc.
X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is...
Surgical Devices·192 affected·Oct 12, 2016
High RiskFDA
Zimmer Biomet, Inc.
ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by ...
Surgical Devices·20 affected·Oct 11, 2016
High RiskFDA
Accessclosure, Inc., A Cardinal Health Company
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the ilio...
Surgical Devices·6 affected·Oct 6, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Cathete...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Cathe...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Cardiology: Boston Scientific Guider Softip XF Guide Catheters...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters a...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters a...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters ar...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Intuitive Surgical, Inc.
da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical End...
Surgical Devices·677 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Alphatec Spine, Inc.
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for pos...
Surgical Devices·16,972 affected·Oct 5, 2016
High RiskFDA
C.r. Bard, Inc.
Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone,...
Surgical Devices·10,290 affected·Oct 5, 2016
High RiskFDA
Maquet Medical Systems Usa
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interfa...
Surgical Devices·9 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Cath...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters a...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Covidien Llc
Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number ...
Surgical Devices·4,950 affected·Sep 29, 2016
RecallFDA
Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Ite...
Surgical Devices·145 affected·Sep 28, 2016
RecallFDA
Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Nu...
Surgical Devices·80 affected·Sep 28, 2016
RecallFDA
Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item N...
Surgical Devices·162 affected·Sep 28, 2016
High RiskFDA
Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Ite...
Surgical Devices·7 affected·Sep 28, 2016
RecallFDA
Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Nu...
Surgical Devices·996 affected·Sep 28, 2016
RecallFDA
Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Nu...
Surgical Devices·751 affected·Sep 28, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that...
Surgical Devices·120 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stopcocks and Admin Set, Item No. 46114-80 The Tr...
Surgical Devices·20 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The Transpac Disposable Straight Pressure Transducer (DSPT...
Surgical Devices·200 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20 The Transpac Disposable Straight Pressure Tra...
Surgical Devices·880 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRO...
Surgical Devices·1,960 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP), Item No. 42586-05 The Transpac Di...
Surgical Devices·800 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 The Transpac Disposable Straight Pressure Transducer (DSPT...
Surgical Devices·70 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpac Disposable Straight Pressure Transducer (DSPT)...
Surgical Devices·370 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravasc...
Surgical Devices·60 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-46106-45 The Transpac Disposable Straigh...
Surgical Devices·140 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42607-05 The Transpac Dis...
Surgical Devices·2,240 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 The Transpac Disposable Straight Pressure Transducer (DSPT) is...
Surgical Devices·235 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 46047-17 The Transpac Disposable Straight Pressure Transduc...
Surgical Devices·130 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-65 The Transpac Disposable Straight ...
Surgical Devices·10 affected·Sep 27, 2016