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Medical Devices
List of Device Recalls
FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.
Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The links give details about what to do if you own or use one of these products.
Please note that FDA now lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. You can find the date that a firm initiated a recall in the text of the recall notice.
2010 Medical Device Recalls
Listed by date posted on FDA website
Device Name | Date |
AngioScore Inc. - AngioSculpt "EX" PTCA Scoring Balloon Catheter
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09/08/10
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Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls)
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08/26/10
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Ikaria Holdings, INOMAX DS Drug Delivery System
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08/23/10
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St. Jude Medical 6 French Engage™ Introducer Devices
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08/13/10
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Cook Medical - Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube
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08/04/10
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Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System
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07/20/10
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Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser
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07/15/10
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Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System
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07/02/10
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Physio-Control Inc., LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors
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07/02/10
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Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED™ and Lifeline AED® Semi-automatic External Defibrillators
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06/14/10
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Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol
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06/10/10
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GE Healthcare Aisys and Avance Anesthesia Systems
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05/17/10
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Certain Cuffed Shiley Tracheostomy Tubes
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05/17/10
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Cardiac Science Corporation, Powerheart, CardioVive, Nihon Kohden, and GE Responder Automated External Defibrillators (AEDs)
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04/30/10
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Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator
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04/22/10
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Teleflex Incorporated - Arrow International Custom Intravenous (IV) Administration Products (IV Tubing Sets and Accessories) and Certain Arrow Arterial Embolectomy Catheters
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04/08/10
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Four Class I Recalls: Becton, Dickinson (BD) and Company, Q-Syte Luer Access Split Septum and Numerous Products Containing the Q-Syte Luer Access Split Septum Repackaged and Distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.
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03/30/10
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Gyrus ACMI, Inc. Micron Bobbin Vent Tube T, 1.27 mm
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03/17/10
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Baylis Medical Company Inc., Torflex Transseptal Guiding Sheath
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03/11/10
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Beckman Coulter Inc., UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell
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03/10/10
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Abiomed, Inc., AB5000 Circulatory Support System
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03/10/10
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Cardiac Science Corporation - Powerheart, Cardiovive, NK, and Responder Automated External Defibrillators (AEDs)
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03/08/10
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Thomas Medical Products Inc., Transseptal Sheath Introducer Kits
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03/08/10
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Baxter HomeChoice and HomeChoice PRO
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03/03/10
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Exelint International Inc. - Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch+" Safety Huber Infusion Sets
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02/26/10
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StatSpin, Inc., doing business as IRIS Sample Processing, StatSpin Express 4 Centrifuges, Model #510
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02/26/10
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Thomas Medical Products Inc., Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport
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02/04/10
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Hettich Instruments Management I, Hettich Centrifuges with 2050 and 2076 Plastic Rotors
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01/28/10
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Edwards Lifesciences Inc., Aquarius Hemodialysis System
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01/28/10
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ev3 Endovascular, Inc., Trailblazer Support Catheter
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01/05/10
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