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.
Recent Medical Device Recalls
Listed by date posted on FDA website.
| Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube - Mislabeling | 07/22/13 |
| Medtronic MiniMed Paradigm Insulin Infusion | 07/12/13 |
| Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blades | 07/10/13 |
| Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps – Feed Through Failure | 06/28/13 |
| Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps – Failure of Priming Bolus | 06/28/13 |
| Medtronic Sutureless Connector Intrathecal Catheter Products – Catheter Occlusion | 06/28/13 |
| Medtronic Xomed, Inc., NIM Trivantage EMG Endotracheal Tube | 06/21/13 |
| Respironics California, Inc., V60 Ventilators | 06/20/13 |
| Endologix, Inc., AFX Introducer System | 06/18/13 |
| Symbios GOPump and GOBlock Kits | 06/12/13 |
| Nephron Pharmaceuticals Corporation – EZ Breathe Atomizer | 06/03/13 |
| Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent | 05/24/13 |
| Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters | 05/20/13 |
| Maquet SERVO-i Ventilator Battery Module | 05/07/13 |
| Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit | 05/07/13 |
| Cardinal Health – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit | 05/07/13 |
| Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators | 05/01/13 |
| Hospira Inc., GemStar Infusion System - Damage from Battery Leakage | 05/01/13 |
| Hospira Inc., GemStar Infusion System, Lithium Battery - Low Voltage | 04/29/13 |
| Engineered Medical Systems, Inc., SealFlex Single Port Ribbed Mask (Infant) | 04/24/13 |
| GE Healthcare, Giraffe OmniBed and Giraffe Incubator | 04/24/13 |
| LifeScan, Inc., OneTouch Verio IQ Blood Glucose Meter | 04/23/13 |
| CareFusion Corporation, Alaris PC Unit (Model 8015) with Software Version 9.12 | 04/22/13 |
| Smith's Medical ASD, Inc., BCI Remote Alarm Cables (NO=Normally Open, NC=Normally Closed), used with 9004 the Capnocheck Capnography (Plus or Sleep) System, Reorder Numbers: WW3398NO & WW3398NC | 04/09/13 |
| Stryker Orthopaedics – ShapeMatch Cutting Guide | 04/18/13 |
| Animas Corporation 2020 Insulin Infusion Pump | 04/05/13 |
| Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves, Model Numbers 8210, 8211, 8215, and 8216 | 03/27/13 |
| Spacelabs Medical, Inc., Spacelabs Anesthesia Workstations and Service Kits | 03/26/13 |
| Symbios Medical Products, LLC, GOPump Elastomeric Infusion PumpKit, Part Number 510076 | 03/18/13 |
| Ad-Tech Medical Instrument Corporation, Macro Micro Subdural Electrodes | 03/07/13 |
| Lumenis Limited, Lumenis VersaCut Tissue Morcellator | 02/25/13 |
| DePuy Orthopaedics, Inc – LPS Diaphyseal Sleeve | 02/22/13 |
| GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems, and the Giraffe and Panda Bag and Mask Resuscitation Systems | 02/14/13 |
| St. Jude Medical, AMPLATZER TorqVue FX Delivery System | 02/12/13 |
| Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower | 02/07/13 |
| Vycor Medical, Inc., Vycor Viewsite Brain Access System (VBAS) | 01/30/13 |
| Bausch and Lomb 27G Sterile Cannula Packed in Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate (Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) Ophthalmic Viscosurgical Device | 01/23/13 |
| Fisher and Paykel Healthcare – Reusable Breathing Circuit | 01/07/13 |
| Praxair Inc., Grab ‘n Go Vantage Portable Oxygen Cylinder Units |
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