Medical Devices
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Medical Device Safety
FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. The lists below show recent medical device recalls and other FDA safety communications. Other safety communications can be found using the links on the left side of this page. For additional information, contact us at: 1-800-638-2041 or dsmica@fda.hhs.gov.
Recent Medical Device Recalls
| Device Name |
Date Posted |
| Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters |
05/20/13 |
| Maquet SERVO-i Ventilator Battery Module |
05/07/13 |
| Cardinal Health – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit |
05/07/13 |
| Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit |
05/07/13 |
| Hospira Inc., GemStar Infusion System - Damage from Battery Leakage |
05/01/13 |
| Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators |
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 |
| Stryker Orthopaedics – ShapeMatch Cutting Guide |
04/18/13 |
| 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 |
| 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 |
Recent Medical Device Safety Communications
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