Skip to main content
High RiskFDA
Back 2 Basics Direct Llc
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to prov...
Medical Devices·10 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing ...
Diagnostic Devices·5 affected·Jun 29, 2018
High RiskFDA
Quasar Bio-tech, Inc.
Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Medical Devices·6,783 affected·Jun 29, 2018
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatm...
Medical Devices·7 affected·Jun 29, 2018
High RiskFDA
Integra Lifesciences Corp.
MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient d...
Surgical Devices·409 affected·Jun 29, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector ...
Diagnostic Devices·667 affected·Jun 29, 2018
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Comput...
Cardiac Devices·1 affected·Jun 29, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube an...
Diagnostic Devices·699 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of cl...
Diagnostic Devices·35 affected·Jun 29, 2018
High RiskFDA
Raysearch Laboratories Ab
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, Ray...
Medical Devices·746 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical...
Diagnostic Devices·115 affected·Jun 29, 2018
High RiskFDA
Luminex Corporation
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner La...
Diagnostic Devices·153 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinic...
Diagnostic Devices·45 affected·Jun 29, 2018
High RiskFDA
Integra Lifesciences Corp.
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to suppor...
Surgical Devices·1 affected·Jun 29, 2018
High RiskFDA
Pfizer
Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, ...
Injectable Drugs·234,680 affected·Jun 28, 2018
High RiskFDA
Lupin Somerset
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manuf...
Oral Drugs·3,456 affected·Jun 28, 2018
High RiskFDA
Envoy Medical Corporation
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable M...
Medical Implants·4 affected·Jun 28, 2018
High RiskFDA
Bayer Medical Care, Inc.
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. ...
Medical Devices·1 affected·Jun 28, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Single Detector (Stitching Patient Support) 712020
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
Diagnostic Devices·2 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Biomerieux, Inc.
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an aut...
Medical Devices·151 affected·Jun 27, 2018
High RiskFDA
Elekta Instrument Ab
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Medical Devices·52 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Genicon, Inc.
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use o...
Medical Devices·1,550 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Upgrades (Stitching Patient Support) 712083
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Biomerieux, Inc.
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is ...
Medical Devices·8 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
Diagnostic Devices·2 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 (Stitching Patient Support) 712225
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
CombiDiagnost R90 (Stitching Patient Support) 709030
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monit...
Respiratory Devices·128 affected·Jun 26, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHC...
Respiratory Devices·128 affected·Jun 26, 2018
High RiskFDA
La Vita Compounding Pharmacy, Llc
Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Phar...
Injectable Drugs·17,610 affected·Jun 25, 2018
High RiskFDA
La Vita Compounding Pharmacy, Llc
Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compou...
Injectable Drugs·19,040 affected·Jun 25, 2018