Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Baxter Healthcare Corp.
CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dial...
Medical Devices·35,460 affected·Feb 25, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 0743...
Medical Devices·871 affected·Feb 23, 2013
High RiskFDA
Aperio Technologies Inc
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. ...
Medical Devices·364 affected·Feb 22, 2013
High RiskFDA
Kerr/pentron, Dba Kerr Corporation And Pentron Clinical
Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirec...
Medical Devices·40,819 affected·Feb 22, 2013
High RiskFDA
Bacterin International, Inc.
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Medical Devices·165 affected·Feb 21, 2013
High RiskFDA
Orthopedic Alliance Llc
Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium ...
Medical Devices·26 affected·Feb 20, 2013
High RiskFDA
Trumpf Medical Systems, Inc.
Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity...
Medical Devices·287 affected·Feb 19, 2013
High RiskFDA
Hospira Inc.
Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions ...
Medical Devices·48,050 affected·Feb 19, 2013
High RiskFDA
Tecan Us, Inc.
Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts a...
Medical Devices·12 affected·Feb 19, 2013
High RiskFDA
Biomerieux Inc
VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbish...
Medical Devices·3 affected·Feb 18, 2013
High RiskFDA
Biomerieux Inc
VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbish...
Medical Devices·3 affected·Feb 18, 2013
High RiskFDA
Biomerieux Inc
VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc71...
Medical Devices·3 affected·Feb 18, 2013
RecallFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Co...
Medical Devices·180 affected·Feb 15, 2013
High RiskFDA
Unimed Surgical Products, Inc.
PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.
Medical Devices·120,416 affected·Feb 15, 2013
High RiskFDA
Raysearch Laboratories Ab
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy T...
Medical Devices·70 affected·Feb 15, 2013
Medium RiskFDA
Becton Dickinson & Company
BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Comp...
Medical Devices·236,400 affected·Feb 14, 2013
High RiskFDA
Polymedco, Inc
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in...
Medical Devices·229,600 affected·Feb 12, 2013
High RiskFDA
Polymedco, Inc
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in ...
Medical Devices·355,350 affected·Feb 12, 2013
High RiskFDA
Elekta, Inc.
Monaco RTP System. Radiation treatment planning.
Medical Devices·13 affected·Feb 11, 2013
High RiskFDA
Innominata Dba Genbio
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positiv...
Medical Devices·195 affected·Feb 11, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia The...
Medical Devices·30,000 affected·Feb 8, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product U...
Medical Devices·30,000 affected·Feb 8, 2013
RecallFDA
Ultradent Products, Inc.
Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxi...
Medical Devices·124 affected·Feb 8, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a vari...
Medical Devices·58 affected·Feb 7, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
Medical Devices·775 affected·Feb 7, 2013
High RiskFDA
Smith & Nephew Inc
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith ...
Medical Devices·90 affected·Feb 7, 2013
High RiskFDA
Agfa Corp.
CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used t...
Medical Devices·17 affected·Feb 7, 2013
High RiskFDA
Ebi, Llc
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle s...
Medical Devices·59 affected·Feb 7, 2013
High RiskFDA
Hospira Inc.
Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise deli...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides p...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise deliv...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Biomerieux Inc
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibili...
Medical Devices·4 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of device...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devic...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise deli...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise deliv...
Medical Devices·357,778 affected·Feb 6, 2013
High RiskFDA
Endogastric Solutions Inc
EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-L...
Medical Devices·190 affected·Feb 4, 2013
High RiskFDA
Spinenet
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Medical Devices·100 affected·Feb 4, 2013
High RiskFDA
Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump ...
Medical Devices·20,311 affected·Feb 4, 2013
RecallFDA
Ultradent Products, Inc.
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC....
Medical Devices·32 affected·Feb 4, 2013
High RiskFDA
Hospira Inc.
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood an...
Medical Devices·2,791 affected·Feb 4, 2013
RecallFDA
Ultradent Products, Inc.
Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Us...
Medical Devices·100 affected·Feb 4, 2013
High RiskFDA
Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump ...
Medical Devices·35,596 affected·Feb 4, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·363,892 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·21,703 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and ca...
Medical Devices·179 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·21,551 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·10,609 affected·Feb 1, 2013