Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Ca...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta duri...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula ...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch ...
Medical Devices·133,793 affected·May 9, 2012
CriticalFDA
Natus Medical Incorporated
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-i...
Medical Devices·324 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Covidien Lp
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, g...
Medical Devices·13,531 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Covidien Lp
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gy...
Medical Devices·50,698 affected·May 9, 2012
High RiskFDA
Raysearch Laboratories Ab
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Produ...
Medical Devices·19 affected·May 9, 2012
High RiskFDA
Jk Products & Services, Inc
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
Medical Devices·598 affected·May 7, 2012
High RiskFDA
Civco Medical Instruments Inc
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRA...
Medical Devices·24 affected·May 7, 2012
High RiskFDA
Civco Medical Instruments Inc
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, ...
Medical Devices·30 affected·May 7, 2012
High RiskFDA
Non-invasive Monitoring Systems, Inc.
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautio...
Medical Devices·2 affected·May 7, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer re...
Medical Devices·241 affected·May 7, 2012
High RiskFDA
Mti Precision Products Llc.
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
Medical Devices·134 affected·May 7, 2012
High RiskFDA
Interactive Motion Technologies, Inc.
Robotic hand accessory to InMotion Arm, rehabilitation robot.
Medical Devices·8 affected·May 5, 2012
High RiskFDA
Stanley Security Solutions, Inc.
Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to...
Medical Devices·176 affected·May 4, 2012
CriticalFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Co...
Medical Devices·530 affected·May 4, 2012
High RiskFDA
Stanley Security Solutions, Inc.
Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help re...
Medical Devices·2,754 affected·May 4, 2012
CriticalFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fir...
Medical Devices·683 affected·May 4, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
Medical Devices·5 affected·Apr 30, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Medical Devices·9 affected·Apr 30, 2012
CriticalFDA
Accutron Inc
Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Prod...
Medical Devices·220 affected·Apr 29, 2012
CriticalFDA
Accutron Inc
CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Medical Devices·220 affected·Apr 29, 2012
CriticalFDA
Accutron Inc
Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13...
Medical Devices·220 affected·Apr 29, 2012
High RiskFDA
Microaire Surgical Instruments, Llc
Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: ...
Medical Devices·15 affected·Apr 26, 2012
High RiskFDA
Stryker Spine
The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW...
Medical Devices·40 affected·Apr 25, 2012
RecallFDA
Ormco/sybronendo
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspi...
Medical Devices·148 affected·Apr 24, 2012
High RiskFDA
Roche Molecular Systems, Inc.
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be use...
Medical Devices·1,292 affected·Apr 23, 2012
RecallFDA
Sigma
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and e...
Medical Devices·2,048 affected·Apr 23, 2012
High RiskFDA
Stryker Spine
LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the ...
Medical Devices·30 affected·Apr 23, 2012
High RiskFDA
Ge Healthcare It
The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The...
Medical Devices·53 affected·Apr 19, 2012
High RiskFDA
Medrad Inc
Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medicati...
Medical Devices·1,229 affected·Apr 18, 2012
High RiskFDA
Medrad Inc
Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and o...
Medical Devices·1,229 affected·Apr 18, 2012
High RiskFDA
Medrad Inc
Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who require medications and other f...
Medical Devices·1,229 affected·Apr 18, 2012
High RiskFDA
Medrad Inc
Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who require medications and oth...
Medical Devices·1,229 affected·Apr 18, 2012
High RiskFDA
Medrad Inc
Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who require medications and other...
Medical Devices·1,229 affected·Apr 18, 2012
High RiskFDA
Medrad Inc
Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and oth...
Medical Devices·1,229 affected·Apr 18, 2012
High RiskFDA
Medrad Inc
Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other flu...
Medical Devices·1,229 affected·Apr 18, 2012
High RiskFDA
Medrad Inc
Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medicatio...
Medical Devices·1,229 affected·Apr 18, 2012
High RiskFDA
Icu Medical, Inc.
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
Medical Devices·0 affected·Apr 17, 2012
High RiskFDA
Icu Medical, Inc.
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
Medical Devices·0 affected·Apr 17, 2012
High RiskFDA
Invacare Corporation
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035...
Medical Devices·227 affected·Apr 16, 2012
High RiskFDA
Varian Medical Systems, Inc.
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brach...
Medical Devices·152 affected·Apr 12, 2012
High RiskFDA
Varian Medical Systems, Inc.
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use i...
Medical Devices·344 affected·Apr 12, 2012