Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, Rx ONLY --- For single use only. --- Device Listing Numbe...
Medical Devices·124 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No. 60041921, STERILE, Rx ONLY --- For single use only. --- De...
Medical Devices·16 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog No. 60010512, STERILE, Rx ONLY --- For single use only. Dev...
Medical Devices·19 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE, Rx ONLY --- For single use only. --- Device Listing Number...
Medical Devices·1,008 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, Rx ONLY --- For single use only. Device Listing Number D13...
Medical Devices·4 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. ...
Medical Devices·2 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·1 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·541 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·13 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·20 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device List...
Medical Devices·70 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Numbe...
Medical Devices·161 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·136 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Lis...
Medical Devices·10 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, STERILE, Rx ONLY ---For single use only. --- Device ...
Medical Devices·1 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D1...
Medical Devices·260 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60020236, STERILE, Rx ONLY --- For single use only. Device L...
Medical Devices·32 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, Rx ONLY --- For single use only. --- Device Listing Number ...
Medical Devices·1 affected·Jan 9, 2015
High RiskFDA
Teleflex Medical
Pilling Modular Verres Body/Obturator, Product Code 140880
Medical Devices·8 affected·Jan 8, 2015
High RiskFDA
Elekta, Inc.
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a ...
Medical Devices·46 affected·Jan 7, 2015
High RiskFDA
Biomet, Inc.
Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
Medical Devices·11 affected·Jan 7, 2015
High RiskFDA
Cincinnati Sub-zero Products Inc
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by ...
Medical Devices·1,390 affected·Jan 7, 2015
High RiskFDA
Clinical Innovations, Llc
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpa...
Medical Devices·827 affected·Jan 5, 2015
High RiskFDA
Natus Medical Incorporated
EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography ...
Medical Devices·248 affected·Jan 2, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver...
Medical Devices·3 affected·Jan 2, 2015
High RiskFDA
Natus Medical Incorporated
EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal...
Medical Devices·928 affected·Jan 2, 2015
High RiskFDA
Advanced Sterilization Products
Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
Medical Devices·2 affected·Dec 24, 2014
High RiskFDA
Shape Medical Systems, Inc
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exer...
Medical Devices·564 affected·Dec 23, 2014
High RiskFDA
Becton Dickinson & Company
BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip ...
Medical Devices·564,000 affected·Dec 19, 2014
High RiskFDA
Spinefrontier, Inc.
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Medical Devices·4 affected·Dec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
Medical Devices·6 affected·Dec 19, 2014
High RiskFDA
Mckesson Israel Ltd.
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage inf...
Medical Devices·9 affected·Dec 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 86...
Medical Devices·10,013 affected·Dec 19, 2014
High RiskFDA
Sunrise Medical (us) Llc
Quickie Q7 Adult Rigid Wheelchair Model EIR4.
Medical Devices·6 affected·Dec 19, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi...
Medical Devices·69,725 affected·Dec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
Medical Devices·6 affected·Dec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
Medical Devices·6 affected·Dec 19, 2014
High RiskFDA
Angiodynamics
Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6....
Medical Devices·43 affected·Dec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Medical Devices·13 affected·Dec 19, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Medical Devices·103 affected·Dec 18, 2014
High RiskFDA
Spinal Elements, Inc
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Pati...
Medical Devices·1,200 affected·Dec 18, 2014
High RiskFDA
St Jude Medical Cardiac Rhythm Management Division
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Medical Devices·257,456 affected·Dec 18, 2014
High RiskFDA
Zimmer Gmbh
CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur i...
Medical Devices·1,908 affected·Dec 17, 2014
High RiskFDA
Zimmer Gmbh
Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint d...
Medical Devices·16 affected·Dec 17, 2014
High RiskFDA
Zimmer Gmbh
Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femu...
Medical Devices·30 affected·Dec 17, 2014
High RiskFDA
Aesculap, Inc.
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ...
Medical Devices·772 affected·Dec 17, 2014
High RiskFDA
Zimmer Gmbh
CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for re...
Medical Devices·6,109 affected·Dec 17, 2014
High RiskFDA
Zimmer Gmbh
Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem comp...
Medical Devices·10,340 affected·Dec 17, 2014