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.
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Medical Devices·2,264,028 affected·Jul 16, 2015
CriticalFDA
Medtronic Cardiovascular Surgery-the Heart Valve Division
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery sys...
Medical Devices·6,912 affected·Jul 15, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
Medical Devices·1 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290
Medical Devices·1 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(64)-4R, Model Number 10248672
Medical Devices·1 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
Medical Devices·2 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(40)-4R, Model Number 10248671
Medical Devices·1 affected·Jul 14, 2015
High RiskFDA
Siemens Medical Solutions Usa Inc.
SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
Medical Devices·1 affected·Jul 14, 2015
High RiskFDA
Etac Supply Center Ab
Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal...
Medical Devices·13 affected·Jul 12, 2015
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed b...
Medical Devices·90 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irr...
Medical Devices·20,200 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture rem...
Medical Devices·4,800 affected·Jul 10, 2015
High RiskFDA
Ivoclar Vivadent, Inc.
IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabric...
Medical Devices·27 affected·Jul 9, 2015
High RiskFDA
Aesculap, Inc.
S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tig...
Medical Devices·10 affected·Jul 7, 2015
High RiskFDA
Eizo Corporation
RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intende...
Medical Devices·19 affected·Jul 7, 2015
High RiskFDA
Eizo Corporation
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in di...
Medical Devices·3 affected·Jul 7, 2015
High RiskFDA
Eizo Corporation
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying an...
Medical Devices·2 affected·Jul 7, 2015
CriticalFDA
Philips Electronics North America Corporation
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Medical Devices·5,672 affected·Jul 6, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (...
Medical Devices·37 affected·Jul 6, 2015
High RiskFDA
Philips Electronics North America Corporation
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-12...
Medical Devices·3,158 affected·Jul 6, 2015
High RiskFDA
Mrp, Llc Dba Amusa
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Medical Devices·551 affected·Jul 2, 2015
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Spirit One A-C Powered Hospital Bed
Medical Devices·143 affected·Jul 2, 2015
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Spirit One A-C Powered Hospital Bed
Medical Devices·143 affected·Jul 2, 2015
High RiskFDA
Silhouette Lift, Inc.
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated pos...
Medical Devices·2,260 affected·Jul 2, 2015
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery...
Medical Devices·74 affected·Jul 1, 2015
High RiskFDA
Remel Inc
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic stre...
Medical Devices·1,859 affected·Jun 30, 2015
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Medical Devices·33 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and ...
Medical Devices·0 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Ope...
Medical Devices·256 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Medical Devices·60 affected·Jun 30, 2015
High RiskFDA
Becton Dickinson & Co.
Enterococcus Screen Agar QUAD Plate
Medical Devices·770 affected·Jun 29, 2015
High RiskFDA
Becton Dickinson & Co.
Vancomycin Screen Agar
Medical Devices·60,840 affected·Jun 29, 2015
RecallFDA
Baxter Healthcare Corp.
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult...
Medical Devices·29,355 affected·Jun 29, 2015
RecallFDA
Getinge Disinfection Ab
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and lab...
Medical Devices·20 affected·Jun 26, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the bo...
Medical Devices·32,296 affected·Jun 26, 2015
High RiskFDA
Hardy Diagnostics
HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sle...
Medical Devices·1,500 affected·Jun 24, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
Medical Devices·16,992 affected·Jun 24, 2015
High RiskFDA
Ergosafe Products, Llc (dba) Prism Medical
Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification of 440 lbs (200 kg...
Medical Devices·7,105 affected·Jun 24, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following u...
Medical Devices·16,992 affected·Jun 24, 2015
High RiskFDA
Encore Medical, Lp
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Medical Devices·10 affected·Jun 24, 2015
RecallFDA
Becton Dickinson & Company
BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, ...
Medical Devices·238 affected·Jun 23, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 soft...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 soft...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4...
Medical Devices·4,007 affected·Jun 22, 2015
High RiskFDA
Draeger Medical, Inc.
Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and rec...
Medical Devices·373 affected·Jun 22, 2015
High RiskFDA
Medtronic Minimed Inc.
MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-17...
Medical Devices·1,936 affected·Jun 19, 2015
High RiskFDA
Argon Medical Devices, Inc
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBM...
Medical Devices·10,290 affected·Jun 18, 2015
High RiskFDA
Argon Medical Devices, Inc
Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; B...
Medical Devices·6,390 affected·Jun 18, 2015