Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Aesculap Implant Systems
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated...
Medical Devices·8 affected·Feb 21, 2012
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Medical Devices·3 affected·Feb 21, 2012
High RiskFDA
Vital Signs Devices, A Ge Healthcare Company
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, M...
Medical Devices·11,803 affected·Feb 20, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor...
Medical Devices·10,250 affected·Feb 17, 2012
High RiskFDA
Covidien Llc Dba Uni-patch
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is appli...
Medical Devices·28,138 affected·Feb 9, 2012
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended f...
Medical Devices·2,437 affected·Feb 9, 2012
High RiskFDA
Covidien Llc Dba Uni-patch
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied direct...
Medical Devices·3,290 affected·Feb 9, 2012
High RiskFDA
Covidien Llc Dba Uni-patch
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that i...
Medical Devices·2,014 affected·Feb 9, 2012
High RiskFDA
Afassco Inc
The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids...
Medical Devices·1,956 affected·Feb 8, 2012
High RiskFDA
Hospira Inc.
*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusi...
Medical Devices·1 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that...
Medical Devices·12,618 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that...
Medical Devices·11,973 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devi...
Medical Devices·12,348 affected·Feb 5, 2012
High RiskFDA
Orthosensor
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.co...
Medical Devices·9 affected·Feb 4, 2012
High RiskFDA
Roche Molecular Systems, Inc.
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the CO...
Medical Devices·2,132 affected·Feb 1, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Dis...
Medical Devices·532 affected·Jan 26, 2012
High RiskFDA
Ge Healthcare, Llc
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966;...
Medical Devices·1,296 affected·Jan 23, 2012
High RiskFDA
Nihon Kohden America Inc
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifi...
Medical Devices·477 affected·Jan 19, 2012
High RiskFDA
Stryker Spine
Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 htt...
Medical Devices·273 affected·Jan 13, 2012
High RiskFDA
Vital Scientific N.v.
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
Medical Devices·4 affected·Jan 10, 2012
High RiskFDA
The Anspach Effort, Inc.
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Medical Devices·16 affected·Jan 9, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corpor...
Medical Devices·16,913 affected·Dec 29, 2011
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker Fran...
Medical Devices·41 affected·Dec 29, 2011
High RiskFDA
Us Endoscopy Group Inc
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampl...
Medical Devices·393 affected·Dec 22, 2011
High RiskFDA
Church & Dwight Inc
Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08...
Medical Devices·1 affected·Dec 22, 2011
High RiskFDA
Church & Dwight Inc
Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Prin...
Medical Devices·0 affected·Dec 22, 2011
High RiskFDA
Church & Dwight Inc
Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton...
Medical Devices·0 affected·Dec 22, 2011
High RiskFDA
Church & Dwight Inc
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufactured for Church and Dwight Co., Inc....
Medical Devices·0 affected·Dec 22, 2011
High RiskFDA
Advanced Neuromodulation Systems Inc.
Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain ...
Medical Devices·25 affected·Dec 19, 2011
High RiskFDA
Advanced Neuromodulation Systems Inc.
The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of...
Medical Devices·30,560 affected·Dec 19, 2011
High RiskFDA
Ormco/sybronendo
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Medical Devices·4,543 affected·Dec 12, 2011
High RiskFDA
Progressive Medical Inc
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamage...
Medical Devices·70 affected·Dec 9, 2011
High RiskFDA
Tripath Imaging, Inc.
PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces S...
Medical Devices·201 affected·Dec 8, 2011
High RiskFDA
Tripath Imaging, Inc.
PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produce...
Medical Devices·18 affected·Dec 8, 2011
High RiskFDA
Sunquest Information Systems, Inc.
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Medical Devices·127 affected·Dec 5, 2011
High RiskFDA
Kerr Corporation
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom Sy...
Medical Devices·1,330 affected·Nov 17, 2011
RecallFDA
Sunquest Information Systems, Inc.
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Medical Devices·127 affected·Nov 15, 2011
High RiskFDA
Us Endoscopy Group Inc
Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens...
Medical Devices·1,153 affected·Nov 14, 2011
High RiskFDA
Shimadzu Medical Systems
0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name...
Medical Devices·288 affected·Oct 28, 2011
High RiskFDA
Shimadzu Medical Systems
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile ...
Medical Devices·133 affected·Oct 28, 2011
High RiskFDA
Shimadzu Medical Systems
0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the ...
Medical Devices·3 affected·Oct 28, 2011
High RiskFDA
Progressive Medical Inc
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamage...
Medical Devices·124 affected·Oct 28, 2011
High RiskFDA
Shimadzu Medical Systems
0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospi...
Medical Devices·5 affected·Oct 28, 2011
High RiskFDA
Philips Healthcare Inc.
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Medical Devices·11 affected·Oct 19, 2011
High RiskFDA
Scc Soft Computer
SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a labora...
Medical Devices·88 affected·Oct 17, 2011
High RiskFDA
Raysearch Laboratories Ab
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial na...
Medical Devices·20 affected·Oct 10, 2011
High RiskFDA
Orthosoft, Inc. Dba Zimmer Cas
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of ...
Medical Devices·105 affected·Oct 6, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in ...
Medical Devices·3 affected·Sep 30, 2011