Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Philips Medical Systems, Inc.
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeab...
Medical Devices·79 affected·Nov 20, 2014
High RiskFDA
Brainlab Ag
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radi...
Medical Devices·1,412 affected·Nov 19, 2014
High RiskFDA
Natus Medical Incorporated
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Medical Devices·1,907 affected·Nov 19, 2014
High RiskFDA
Kci Usa, Inc.
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H2...
Medical Devices·1,139 affected·Nov 19, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator sy...
Medical Devices·3 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneo...
Medical Devices·86 affected·Nov 19, 2014
CriticalFDA
Halyard Health
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway m...
Medical Devices·430 affected·Nov 17, 2014
CriticalFDA
Halyard Health
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway m...
Medical Devices·400 affected·Nov 17, 2014
CriticalFDA
Halyard Health
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway m...
Medical Devices·80 affected·Nov 17, 2014
High RiskFDA
Transmotion Medical Inc
Powered stretcher chair used during facial and eye surgeries. One chair per package.
Medical Devices·1,127 affected·Nov 14, 2014
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and P...
Medical Devices·8 affected·Nov 13, 2014
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) a...
Medical Devices·8 affected·Nov 13, 2014
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (C...
Medical Devices·4 affected·Nov 13, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for ...
Medical Devices·1,064 affected·Nov 12, 2014
High RiskFDA
Teleflex Medical
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal in...
Medical Devices·14,000 affected·Nov 12, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System ...
Medical Devices·149 affected·Nov 11, 2014
High RiskFDA
Ebi, Llc
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize...
Medical Devices·193 affected·Nov 11, 2014
High RiskFDA
Vision Rt Inc
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before ...
Medical Devices·55 affected·Nov 11, 2014
RecallFDA
Aesculap, Inc.
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ve...
Medical Devices·4 affected·Nov 11, 2014
High RiskFDA
Ge Inspection Technologies, Lp
GE Optional Laser Centering Device X-ray generator.
Medical Devices·25 affected·Nov 10, 2014
RecallFDA
Tecan Us, Inc.
Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high perfo...
Medical Devices·0 affected·Nov 10, 2014
High RiskFDA
Ge Inspection Technologies, Lp
GE Cabinet X-ray systems
Medical Devices·11 affected·Nov 10, 2014
RecallFDA
Tecan Us, Inc.
Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performa...
Medical Devices·8 affected·Nov 10, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head i...
Medical Devices·19 affected·Nov 7, 2014
High RiskFDA
Ion Beam Applications S.a.
adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for ...
Medical Devices·1 affected·Nov 7, 2014
High RiskFDA
Fisher & Paykel Healthcare, Ltd.
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Asse...
Medical Devices·661 affected·Nov 6, 2014
High RiskFDA
Philips Ultrasound, Inc.
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xc...
Medical Devices·52 affected·Nov 5, 2014
High RiskFDA
Gambro Renal Products Inc
Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use dev...
Medical Devices·20 affected·Nov 5, 2014
High RiskFDA
Gambro Renal Products Inc
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices...
Medical Devices·20 affected·Nov 5, 2014
High RiskFDA
Custom Healthcare Systems, Inc.
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Medical Devices·3 affected·Nov 5, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Medical Devices·85 affected·Nov 4, 2014
High RiskFDA
Aircraft Medical Limited
McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Prod...
Medical Devices·40,900 affected·Nov 4, 2014
High RiskFDA
Advanced Sterilization Products
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpo...
Medical Devices·19,978 affected·Nov 4, 2014
High RiskFDA
Advanced Sterilization Products
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purp...
Medical Devices·19,978 affected·Nov 4, 2014
High RiskFDA
Elekta, Inc.
MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It suppor...
Medical Devices·15 affected·Nov 3, 2014
High RiskFDA
Bard Access Systems
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Medical Devices·2,532 affected·Nov 3, 2014
High RiskFDA
Accuray Incorporated
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for tr...
Medical Devices·84 affected·Oct 31, 2014
High RiskFDA
Us Endoscopy Group Inc
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corru...
Medical Devices·100 affected·Oct 31, 2014
High RiskFDA
Carestream Health, Inc.
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Medical Devices·59 affected·Oct 30, 2014
High RiskFDA
Alcon Research, Ltd.
INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082,...
Medical Devices·147,473 affected·Oct 30, 2014
High RiskFDA
Remel Inc
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a...
Medical Devices·79 affected·Oct 29, 2014
High RiskFDA
Synthes, Inc.
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the ...
Medical Devices·6 affected·Oct 29, 2014
High RiskFDA
Cooper Vision Caribbean Corp.
Soft Contact Lens
Medical Devices·1,170 affected·Oct 28, 2014
High RiskFDA
Arthrocare Medical Corporation
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Int...
Medical Devices·23,119 affected·Oct 27, 2014
RecallFDA
Agfa Healthcare Corp.
Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM
Medical Devices·142 affected·Oct 24, 2014
High RiskFDA
Ge Healthcare
GE Discovery MR950 MRI system
Medical Devices·5 affected·Oct 24, 2014
High RiskFDA
Discus Dental Llc
Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 p...
Medical Devices·20,251 affected·Oct 24, 2014
CriticalFDA
Synthes (usa) Products Llc
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix...
Medical Devices·24 affected·Oct 23, 2014