Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation...
Medical Devices·648 affected·Jun 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation...
Medical Devices·992 affected·Jun 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulatio...
Medical Devices·648 affected·Jun 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation...
Medical Devices·992 affected·Jun 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 h...
Medical Devices·648 affected·Jun 22, 2012
High RiskFDA
Elekta, Inc.
Focal SIM Planning of radiation therapy
Medical Devices·38 affected·Jun 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6...
Medical Devices·992 affected·Jun 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6...
Medical Devices·648 affected·Jun 21, 2012
High RiskFDA
Elekta, Inc.
Monaco Product Usage: Planning of radiation therapy
Medical Devices·38 affected·Jun 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulati...
Medical Devices·992 affected·Jun 21, 2012
RecallFDA
Terumo Cardiovascular Systems Corporation
System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal...
Medical Devices·3 affected·Jun 20, 2012
High RiskFDA
Gulf South Medical Supply Inc
Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usa...
Medical Devices·275 affected·Jun 20, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Medical Devices·15 affected·Jun 20, 2012
High RiskFDA
Molded Products Inc
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Medical Devices·1,200 affected·Jun 19, 2012
RecallFDA
Advanced Sterilization Products
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose steril...
Medical Devices·7,550 affected·Jun 19, 2012
RecallFDA
Advanced Sterilization Products
STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose ster...
Medical Devices·7,495 affected·Jun 19, 2012
High RiskFDA
Cardiovascular Systems, Inc.
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxid...
Medical Devices·27 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 ho...
Medical Devices·461 affected·Jun 18, 2012
High RiskFDA
Varian Medical Systems, Inc. Oncology Systems
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Va...
Medical Devices·7,113 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours ...
Medical Devices·26 affected·Jun 18, 2012
High RiskFDA
Safe N Simple, Llc
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Medical Devices·17,592 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorpo...
Medical Devices·648 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours...
Medical Devices·1,096 affected·Jun 18, 2012
High RiskFDA
Synthes Usa Hq, Inc.
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. ...
Medical Devices·1,602 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 ho...
Medical Devices·310 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours ...
Medical Devices·274 affected·Jun 18, 2012
High RiskFDA
Exactech, Inc.
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
CriticalFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilitie...
Medical Devices·43,862 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Philips Healthcare Inc.
Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic inte...
Medical Devices·226 affected·Jun 14, 2012
High RiskFDA
Integra Life Sci.
The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a S...
Medical Devices·2,389 affected·Jun 14, 2012
High RiskFDA
Orthopediatrics Corp
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients ...
Medical Devices·15 affected·Jun 14, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor...
Medical Devices·10,497 affected·Jun 13, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
Medical Devices·119,262 affected·Jun 13, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
Medical Devices·279 affected·Jun 12, 2012
CriticalFDA
Carestream Health, Inc.
Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 146...
Medical Devices·9,971 affected·Jun 12, 2012
High RiskFDA
Teleflex Medical
Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime...
Medical Devices·14,794 affected·Jun 12, 2012
High RiskFDA
Pdg Product Design Group Inc
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
Medical Devices·153 affected·Jun 12, 2012
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection o...
Medical Devices·21 affected·Jun 12, 2012
High RiskFDA
The Anspach Effort, Inc.
Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
Medical Devices·1 affected·Jun 11, 2012
High RiskFDA
The Anspach Effort, Inc.
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
Medical Devices·4 affected·Jun 11, 2012
CriticalFDA
Stryker Instruments Div. Of Stryker Corporation
Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
Medical Devices·2,657 affected·Jun 8, 2012
High RiskFDA
Impac Medical Systems Inc
MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used fo...
Medical Devices·11 affected·Jun 8, 2012
High RiskFDA
Philips And Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is label...
Medical Devices·15 affected·Jun 8, 2012