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Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall
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HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall
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Class I Medical Device Recall: Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150038 and DEN150057 added)
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Class I Medical Device Recall: Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product The LIFEPAK 15 Monitor/Defibrillator (LP15) Serial Numbers: See full list below Distribution Dates: September 13, 2014, to July 4, 2016 Manufacturing Dates: September 3, 2014 to June…
Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall
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Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall
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Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall
[Posted 02/09/2017] AUDIENCE: Consumer, Emergency Medicine ISSUE: Kingsway Trading Inc. is recalling its 1.06 oz (30g) bottles of “Well Balance Xanthium Siler Combo (Bi Yan Pian)” Batch No. 130401 Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary supplements containing ephedrine alkaloids pose a risk…
The FDA alerts health care providers about potential risks with fluid-filled intragastric balloons
February 9, 2017 Dear Health Care Provider, The FDA has recently received multiple reports for two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity. We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications…