Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008...
Medical Devices·79 affected·Apr 25, 2014
CriticalFDA
Hitachi Medical Systems America Inc
Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended...
Medical Devices·173 affected·Apr 25, 2014
RecallFDA
Siemens Medical Solutions Diagnostics
VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments an...
Medical Devices·19 affected·Apr 25, 2014
High RiskFDA
Medtronic Navigation, Inc.
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TUMOR RES. PACK 9733553 AxiEM S.M.
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
KIT, 9731427, THORACIC TACTILE PROBES
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as ...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue defici...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
ENT PRGM 9734636 ADD FUSION NAV AxiEM
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
MOUSE 9732721 STERILE O-ARM 10PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue defi...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SPHERES 8801071 1/TRAY 12PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficienc...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the r...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
BIT 9733516 2.9mm DRILL STERILE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Baxter Healthcare Corp.
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
Medical Devices·55 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SPHERES 8801075 5/TRAY 12PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue defici...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TUMOR RESECTION KIT 9733607 NON-INVASIVE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SHUNT KIT 9733605 NON-INVASIVE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
INSTRUMENT TRACKER 9733533XOM ENT 1PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
DISP 9730950 STRL SPHERE, 1 PK INSERT
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Elekta, Inc.
Synergy XVI Intended for radiation therapy treatment.
Medical Devices·380 affected·Apr 23, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300...
Medical Devices·3,540 affected·Apr 22, 2014
High RiskFDA
Med-mizer, Inc.
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontou...
Medical Devices·191 affected·Apr 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and...
Medical Devices·2,461,824 affected·Apr 16, 2014
High RiskFDA
Handicare Usa, Inc.
ReTurn 7500/7500 Aid, transfer
Medical Devices·29 affected·Apr 15, 2014
High RiskFDA
Biomet, Inc.
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through so...
Medical Devices·102 affected·Apr 15, 2014
High RiskFDA
Ivoclar Vivadent, Inc.
bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental cur...
Medical Devices·241 affected·Apr 14, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Medical Devices·0 affected·Apr 14, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass proced...
Medical Devices·0 affected·Apr 14, 2014
High RiskFDA
Merit Medical Systems, Inc.
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
Medical Devices·186 affected·Apr 14, 2014
High RiskFDA
Blue Belt Technologies Mn
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Medical Devices·11 affected·Apr 11, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
Medical Devices·16,302 affected·Apr 10, 2014
High RiskFDA
Synthes, Inc.
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Medical Devices·5,114,052 affected·Apr 10, 2014
CriticalFDA
Smiths Medical Asd, Inc.
Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the pati...
Medical Devices·100 affected·Apr 10, 2014
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII01...
Medical Devices·13,115 affected·Apr 9, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monito...
Medical Devices·1,794 affected·Apr 9, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the f...
Medical Devices·4,462 affected·Apr 8, 2014
High RiskFDA
Synthes, Inc.
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For...
Medical Devices·3 affected·Apr 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in d...
Medical Devices·664 affected·Apr 8, 2014
High RiskFDA
Small Bone Innovations, Inc.
SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticul...
Medical Devices·44 affected·Apr 7, 2014
High RiskFDA
Western / Scott Fetzer Company
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Medical Devices·118,325 affected·Apr 7, 2014
High RiskFDA
Smith & Nephew Inc
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203,...
Medical Devices·1,253 affected·Apr 4, 2014
High RiskFDA
Smith & Nephew Inc
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, ...
Medical Devices·1,253 affected·Apr 4, 2014