Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
15,654 recalls
High RiskFDA
Teleflex Medical
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS ...
Medical Devices2,674,650 affectedOct 27, 2016
High RiskFDA
Teleflex Medical
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the o...
Medical Devices2,674,650 affectedOct 27, 2016
High RiskFDA
Teleflex Medical
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral,...
Medical Devices2,674,650 affectedOct 27, 2016
High RiskFDA
Teleflex Medical
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topica...
Medical Devices2,674,650 affectedOct 27, 2016
High RiskFDA
Brainlab Ag
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Medical Devices29 affectedOct 27, 2016
High RiskFDA
Beckman Coulter Inc.
MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility ...
Medical Devices131 affectedOct 25, 2016
High RiskFDA
Trumpf Medical Systems, Inc.
OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 ...
Medical Devices4 affectedOct 25, 2016
High RiskFDA
Domain Surgical, Inc.
FMsealer Open Shears. Model FM3001
Medical Devices70 affectedOct 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Medical Devices23 affectedOct 21, 2016
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy System
Medical Devices6 affectedOct 20, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force, System x-ray, tomography, computed
Medical Devices48 affectedOct 20, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
Medical Devices1,129 affectedOct 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-secti...
Medical Devices3,077 affectedOct 19, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
Medical Devices52,084 affectedOct 19, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Medical Devices62 affectedOct 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-secti...
Medical Devices762 affectedOct 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS system, x-ray, tomography, computed
Medical Devices57 affectedOct 19, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Sterile Disposable Probes sold individually
Medical Devices7,784 affectedOct 19, 2016
High RiskFDA
Teleflex Medical
Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserte...
Medical Devices25,274 affectedOct 18, 2016
High RiskFDA
Spacelabs Healthcare Inc
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal ...
Medical Devices348 affectedOct 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
Medical Devices3 affectedOct 17, 2016
High RiskFDA
Helena Laboratories, Inc.
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Medical Devices65 affectedOct 14, 2016
High RiskFDA
Reshape Medical Inc
ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual B...
Medical Devices114 affectedOct 14, 2016
High RiskFDA
C.r. Bard, Inc.
Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Medical Devices75,089 affectedOct 13, 2016
RecallFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Computed Tomography X-ray system, Model 728306
Medical Devices67 affectedOct 13, 2016
High RiskFDA
Perkinelmer, Inc
PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes...
Medical Devices33,312 affectedOct 13, 2016
RecallFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core Computed Tomography X-ray system, Model 728321
Medical Devices2 affectedOct 13, 2016
RecallFDA
Philips Medical Systems (cleveland) Inc
Brilliance ICT SP Computed Tomography X-ray system, Model 728311
Medical Devices3 affectedOct 13, 2016
RecallFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT Computed Tomography X-ray system, Model 728332
Medical Devices3 affectedOct 13, 2016
High RiskFDA
Baxter Healthcare Corp.
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a s...
Medical Devices22,656 affectedOct 12, 2016
High RiskFDA
Depuy Spine, Inc.
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior...
Medical Devices6 affectedOct 12, 2016
High RiskFDA
Depuy Spine, Inc.
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anteri...
Medical Devices21 affectedOct 12, 2016
High RiskFDA
C.r. Bard, Inc.
C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA...
Medical Devices70 affectedOct 12, 2016
High RiskFDA
Depuy Spine, Inc.
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior ...
Medical Devices1 affectedOct 12, 2016
High RiskFDA
Raysearch Laboratories Ab
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analy...
Medical Devices540 affectedOct 11, 2016
High RiskFDA
Soft Computer Consultants, Inc.
SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. U...
Medical Devices189 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Keyless Driver Product Usage: Pneumatic system
Medical Devices121 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
14cm QD Angle Attachment Product Usage: Pneumatic system
Medical Devices238 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Electric Handpiece EM Hand Control Product Usage: Electric system
Medical Devices32 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
6.8cm Controlled Depth Attachment Product Usage: Pneumatic system
Medical Devices4 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
SMALL ATTACHMENT, J-LATCH
Medical Devices16 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
IMRI AIR CONTROL Product Usage: Pneumatic system
Medical Devices3 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
14cm QD Angle Attachment Product Usage: Product attachment
Medical Devices0 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
XMAX Motor, High Strength Hose Product Usage: Pneumatic system
Medical Devices22 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
Medical Devices297 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Rotating Adult Craniotome Product Usage: Pneumatic system
Medical Devices49 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
Foot Control without Switches, SC2100 Product Usage: Electric system
Medical Devices22 affectedOct 6, 2016
High RiskFDA
The Anspach Effort, Inc.
STANDARD CRANIOTOME, BLACK MAX
Medical Devices148 affectedOct 6, 2016