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U.S. Department of Health and Human Services

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
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 01/02/13
GE Healthcare T-Piece Circuits for the Giraffe and Panda Resuscitation Systems 12/28/12
Zimmer Spine, Inc. - PEEK Ardis Inserter 12/28/12
Medtronic SynchroMed II Implantable Drug Infusion Pump and SynchroMed EL Implantable Drug Infusion Pump 12/21/12
Bunnell Incorporated, Life Pulse High-Frequency Ventilator Patient Circuits 12/21/12
Ventlab Corporation Adult and Pediatric Manual Resuscitators 12/21/12
Ethicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin 12/13/12
Verathon, Inc., Certain GlideScope Video Laryngoscope Reusable Blades 12/12/12
Natus Medical Incorporated, Olympic Cool-Cap System (Revised) 12/12/12
Mindray A3 and A5 Anesthesia Delivery System 11/30/12

Recent Medical Device Safety Communications

FDA Safety Communication Date
FDA Safety Communication: Metal-on-Metal Hip Implants 01/17/13