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
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