Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Hospira Inc.
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pu...
Medical Devices·0 affected·Mar 19, 2013
High RiskFDA
Hospira Inc.
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pu...
Medical Devices·0 affected·Mar 19, 2013
High RiskFDA
Lemaitre Vascular, Inc.
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist ...
Medical Devices·13,560 affected·Mar 18, 2013
CriticalFDA
Hospira Inc.
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use...
Medical Devices·13,000 affected·Mar 18, 2013
CriticalFDA
Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere el...
Medical Devices·13,000 affected·Mar 18, 2013
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use w...
Medical Devices·1,480 affected·Mar 18, 2013
High RiskFDA
Shimadzu Medical Systems
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in...
Medical Devices·200 affected·Mar 18, 2013
High RiskFDA
Clorox Healthcare Holdings, Llc (dba Healthlink)
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
Medical Devices·1,032,700 affected·Mar 18, 2013
High RiskFDA
Clorox Healthcare Holdings, Llc (dba Healthlink)
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
Medical Devices·1,044,600 affected·Mar 18, 2013
CriticalFDA
Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere el...
Medical Devices·13,086 affected·Mar 18, 2013
High RiskFDA
Vital Images, Inc.
Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterpri...
Medical Devices·1,978 affected·Mar 15, 2013
CriticalFDA
Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere el...
Medical Devices·43,840 affected·Mar 15, 2013
CriticalFDA
Mckesson Technologies Inc.
McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and ...
Medical Devices·10 affected·Mar 15, 2013
High RiskFDA
Ge Healthcare It
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities a...
Medical Devices·5 affected·Mar 12, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, Syst...
Medical Devices·515 affected·Mar 12, 2013
High RiskFDA
Custom Ultrasonics, Inc.
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Medical Devices·118 affected·Mar 12, 2013
High RiskFDA
Ge Healthcare It
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities a...
Medical Devices·7 affected·Mar 12, 2013
High RiskFDA
Becton Dickinson & Co.
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.
Medical Devices·521,160 affected·Mar 11, 2013
High RiskFDA
Becton Dickinson & Co.
BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.
Medical Devices·521,160 affected·Mar 11, 2013
High RiskFDA
Becton Dickinson & Co.
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.
Medical Devices·521,160 affected·Mar 11, 2013
High RiskFDA
Hospira Inc.
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-ad...
Medical Devices·8,794 affected·Mar 8, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Medical Devices·81 affected·Mar 8, 2013
High RiskFDA
Hospira Inc.
LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
Medical Devices·69 affected·Mar 8, 2013
High RiskFDA
Ormco/sybronendo
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires ...
Medical Devices·8,210 affected·Mar 8, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the ...
Medical Devices·2 affected·Mar 8, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the fo...
Medical Devices·62 affected·Mar 8, 2013
High RiskFDA
Smith & Nephew Inc
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orth...
Medical Devices·23 affected·Mar 6, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determine...
Medical Devices·4,467 affected·Mar 6, 2013
High RiskFDA
Advanced Orthogonal Equipment, Incorporated
Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adj...
Medical Devices·54 affected·Mar 6, 2013
High RiskFDA
Alere San Diego, Inc.
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (AL...
Medical Devices·38,571 affected·Mar 6, 2013
CriticalFDA
Carefusion Corporation
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and pow...
Medical Devices·9,241 affected·Mar 6, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Philips And Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system....
Medical Devices·23 affected·Mar 4, 2013
High RiskFDA
Steris Corporation
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683...
Medical Devices·1,677 affected·Mar 4, 2013
High RiskFDA
B. Braun Medical, Inc.
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
Medical Devices·1,580 affected·Mar 1, 2013
High RiskFDA
Boston Scientific Crm Corp
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the ...
Medical Devices·2,090 affected·Mar 1, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Medical Devices·3 affected·Feb 28, 2013
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
Medical Devices·2,207 affected·Feb 27, 2013
High RiskFDA
Hospira Inc.
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed...
Medical Devices·8,214 affected·Feb 27, 2013
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.
Medical Devices·2,207 affected·Feb 27, 2013
High RiskFDA
Medtronic Neuromodulation
Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obst...
Medical Devices·848 affected·Feb 27, 2013
High RiskFDA
Intio Inc
INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used ...
Medical Devices·7 affected·Feb 26, 2013
RecallFDA
Siemens Healthcare Diagnostics Inc
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Medical Devices·1 affected·Feb 26, 2013