Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Varian Medical Systems, Inc.
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tu...
Medical Devices·15 affected·Sep 28, 2012
High RiskFDA
Icu Medical, Inc.
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
Medical Devices·60 affected·Sep 28, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW)...
Medical Devices·2,580 affected·Sep 28, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Definium 5000 / 5220493 X-Ray System
Medical Devices·312 affected·Sep 26, 2012
High RiskFDA
Degotzen
DeGotzen XRay unit XGenus Dental X-ray unit.
Medical Devices·159 affected·Sep 26, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up ...
Medical Devices·26 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass pro...
Medical Devices·289 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass...
Medical Devices·1,076 affected·Sep 25, 2012
High RiskFDA
Belmont Instrument Corporation
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
Medical Devices·2,913 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for...
Medical Devices·312 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up ...
Medical Devices·274 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up t...
Medical Devices·81 affected·Sep 25, 2012
CriticalFDA
Winco Mfg., Llc
PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a ...
Medical Devices·95 affected·Sep 24, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass proced...
Medical Devices·126 affected·Sep 24, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedur...
Medical Devices·847 affected·Sep 24, 2012
High RiskFDA
Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
Medical Devices·1,536 affected·Sep 21, 2012
High RiskFDA
Asahi Kasei Medical Co., Ltd., Okatomi Plant
Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
Medical Devices·55,632 affected·Sep 21, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Medical Devices·364 affected·Sep 20, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, ...
Medical Devices·179 affected·Sep 20, 2012
High RiskFDA
Sorin Group Usa, Inc.
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a...
Medical Devices·8 affected·Sep 20, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, region...
Medical Devices·72 affected·Sep 20, 2012
High RiskFDA
Captiva Spine, Inc
CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pe...
Medical Devices·10 affected·Sep 20, 2012
High RiskFDA
Zimmer, Inc.
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for e...
Medical Devices·24 affected·Sep 20, 2012
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Medical Devices·10 affected·Sep 20, 2012
High RiskFDA
Sorin Group Usa, Inc.
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopul...
Medical Devices·12 affected·Sep 20, 2012
High RiskFDA
Sorin Group Usa, Inc.
Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass f...
Medical Devices·2 affected·Sep 19, 2012
High RiskFDA
Sorin Group Usa, Inc.
S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass f...
Medical Devices·5 affected·Sep 19, 2012
High RiskFDA
Sorin Group Usa, Inc.
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass ...
Medical Devices·35 affected·Sep 19, 2012
High RiskFDA
Sorin Group Usa, Inc.
S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass fo...
Medical Devices·2 affected·Sep 19, 2012
High RiskFDA
Trophy Sas
CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for...
Medical Devices·167 affected·Sep 18, 2012
High RiskFDA
Trophy Sas
CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radio...
Medical Devices·167 affected·Sep 18, 2012
High RiskFDA
Trophy Sas
CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for...
Medical Devices·167 affected·Sep 18, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brillian...
Medical Devices·1,474 affected·Sep 18, 2012
High RiskFDA
Instratek, Incorporated
Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger re...
Medical Devices·235 affected·Sep 18, 2012
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of lega...
Medical Devices·422 affected·Sep 14, 2012
High RiskFDA
Zimmer, Inc.
Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individua...
Medical Devices·275,952 affected·Sep 14, 2012
High RiskFDA
Zimmer, Inc.
Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in indivi...
Medical Devices·275,952 affected·Sep 14, 2012
High RiskFDA
Zimmer, Inc.
Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals ...
Medical Devices·275,952 affected·Sep 14, 2012
High RiskFDA
Zimmer, Inc.
Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in i...
Medical Devices·275,952 affected·Sep 14, 2012
High RiskFDA
Zimmer, Inc.
CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surge...
Medical Devices·59 affected·Sep 13, 2012
High RiskFDA
Zimmer, Inc.
CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hi...
Medical Devices·59 affected·Sep 13, 2012
High RiskFDA
Zimmer, Inc.
CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in tota...
Medical Devices·20 affected·Sep 13, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Medical Devices·370 affected·Sep 12, 2012
High RiskFDA
Invacare Corporation
Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
Medical Devices·3 affected·Sep 10, 2012
High RiskFDA
Pioneer Surgical Technology, Inc.
STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
Medical Devices·11 affected·Sep 10, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in ext...
Medical Devices·150 affected·Sep 10, 2012
High RiskFDA
Zimmer, Inc.
Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the appli...
Medical Devices·60 affected·Sep 7, 2012
CriticalFDA
Baxter Healthcare Corp.
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile...
Medical Devices·488,504 affected·Sep 7, 2012