Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core128 Model # 728323, computed tomography x-ray system
Medical Devices·116 affected·Jun 24, 2019
High RiskFDA
Centurion Medical Products Corporation
NOSEBLEED TRAY Kit Code: MNS3885
Medical Devices·30 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 Model # 728231, computed tomography x-ray system
Medical Devices·582 affected·Jun 24, 2019
CriticalFDA
Fenwal Inc
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Softw...
Medical Devices·83 affected·Jun 24, 2019
High RiskFDA
Centurion Medical Products Corporation
EPISTAXIS TRAY Kit Code: MNS10165
Medical Devices·525 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
iCT, Model # 728306, computed tomography x-ray system
Medical Devices·128 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT, Model # 728326, computed tomography x-ray system
Medical Devices·92 affected·Jun 24, 2019
High RiskFDA
Centurion Medical Products Corporation
YNHH SCOPE KIT Kit Code: MNS10475
Medical Devices·644 affected·Jun 24, 2019
CriticalFDA
Fenwal Inc
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of t...
Medical Devices·9,461 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
Medical Devices·12 affected·Jun 24, 2019
High RiskFDA
Origen Biomedical, Inc.
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Medical Devices·6 affected·Jun 24, 2019
High RiskFDA
Elekta, Inc.
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy t...
Medical Devices·12 affected·Jun 24, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios care fusion system
Medical Devices·1 affected·Jun 20, 2019
High RiskFDA
Cincinnati Sub-zero Products Llc, A Gentherm Company
Norm-O-Temp model 111Z
Medical Devices·674 affected·Jun 20, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha VA20/ VA30 mobile X-Ray systems
Medical Devices·1 affected·Jun 20, 2019
High RiskFDA
Pharmaceutical Innovations, Inc.
ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
Medical Devices·71,653 affected·Jun 19, 2019
High RiskFDA
Pharmaceutical Innovations, Inc.
Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
Medical Devices·0 affected·Jun 19, 2019
High RiskFDA
Andover Healthcare Inc.
Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
Medical Devices·1,798 affected·Jun 19, 2019
High RiskFDA
Seca
Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
Medical Devices·254 affected·Jun 19, 2019
High RiskFDA
Andover Healthcare Inc.
Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
Medical Devices·330 affected·Jun 19, 2019
High RiskFDA
Pharmaceutical Innovations, Inc.
ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
Medical Devices·8,982 affected·Jun 19, 2019
High RiskFDA
Andover Healthcare Inc.
Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
Medical Devices·269 affected·Jun 19, 2019
High RiskFDA
Pharmaceutical Innovations, Inc.
ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
Medical Devices·630 affected·Jun 19, 2019
High RiskFDA
Andover Healthcare Inc.
Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Medical Devices·8,500 affected·Jun 19, 2019
High RiskFDA
Epimed International, Inc.
Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LO...
Medical Devices·98 affected·Jun 18, 2019
High RiskFDA
Ad-tech Medical Instrument Corporation
Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
Medical Devices·187,666 affected·Jun 18, 2019
High RiskFDA
Ad-tech Medical Instrument Corporation
LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gask...
Medical Devices·201 affected·Jun 18, 2019
High RiskFDA
Ad-tech Medical Instrument Corporation
Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth El...
Medical Devices·107,757 affected·Jun 18, 2019
High RiskFDA
Epimed International, Inc.
Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LO...
Medical Devices·200 affected·Jun 18, 2019
High RiskFDA
Howmedica Osteonics Corp.
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Medical Devices·11 affected·Jun 18, 2019
High RiskFDA
Coopersurgical, Inc.
LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
Medical Devices·358 affected·Jun 18, 2019
CriticalFDA
Datascope Corp.
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
Medical Devices·16,656 affected·Jun 17, 2019
CriticalFDA
Datascope Corp.
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
Medical Devices·16,656 affected·Jun 17, 2019
CriticalFDA
Datascope Corp.
CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
Medical Devices·16,656 affected·Jun 17, 2019
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Medical Devices·6,197 affected·Jun 17, 2019
CriticalFDA
Datascope Corp.
CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
Medical Devices·16,656 affected·Jun 17, 2019
High RiskFDA
Stanley Security Solutions Inc
STANLEY Healthcare Arial 54315 Network Manager
Medical Devices·137 affected·Jun 14, 2019
High RiskFDA
Coopersurgical, Inc.
Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a ...
Medical Devices·213 affected·Jun 14, 2019
High RiskFDA
Wilson-cook Medical Inc.
Acuject Variable Injection Needle
Medical Devices·24 affected·Jun 14, 2019
High RiskFDA
Coopersurgical, Inc.
Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a ...
Medical Devices·213 affected·Jun 14, 2019
High RiskFDA
Spinefrontier, Inc.
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Medical Devices·6 affected·Jun 13, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis dTC, Model Number 7413078
Medical Devices·98 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
Medical Devices·1,436,228,004 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
Medical Devices·1,436,228,004 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis FA, Model Number 5904441
Medical Devices·4 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
Medical Devices·1,436,228,004 affected·Jun 12, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee floor MN, Model Number 10094142
Medical Devices·23 affected·Jun 12, 2019
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
Medical Devices·1,436,228,004 affected·Jun 12, 2019