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The Web site of the US Food and Drug Administration (http://www.fda.gov) The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of six product centers, one research center, and two offices.  FDA is responsible for ... Full Bio
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Tasty Delicious Bakery Inc. Issues Allergy Alert On Undeclared Eggs In Sugar Bun by FDA Posted in: Blog Posts in Health Education TASTY DELICIOUS BAKERY INC.of Brooklyn, New York is recalling Sugar Bun in 8 oz individually wrapped packages because it may contain eggs. People who have an allergy or sev ... Read on »
Insulet Corporation Issues Voluntary Recall of OmniPod Insulin Management System by FDA Posted in: Blog Posts in Health Education On July 8, 2015, Insulet Corporation (Insulet or the Company) initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Manage ... Read on »
The One Minute Miracle Inc. Issues Voluntary Nationwide Recall of MIRACLE DIET 30 Due to Presence... by FDA Posted in: Blog Posts in Health Education The One Minute Miracle Inc. is voluntarily recalling one lot each of Miracle Diet 30, capsules and Miracle Rock 48. Miracle Diet 30 has been found to contain undeclared ... Read on »
Bimbo Bakeries Voluntary Regional Recall of Certain Limited Breads Produced Under the Sara Lee,... by FDA Posted in: Blog Posts in Health Education Bimbo Bakeries USA has initiated a voluntary regional recall of certain bread products under the Sara Lee®, Kroger®, Bimbo®, Nature’s Harvest®, Great Value and L’Oven Fresh® ... Read on »
Summary Information for: Minerva Endometrial Ablation System by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for Minerva Endometrial Ablation System (P140013). Read on »
Summary Information for: Innova Vascular Self-Expanding Stent System by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for Innova Vascular Self-Expanding Stent System (P140028). Read on »
Class I Medical Device Recall: Elite Biomedical Solutions, Alaris Medley Large Volume Pump (LVP)... by FDA Posted in: Blog Posts in Health Education Elite Biomedical Solutions discovered that the use of this part can result in over or under infusion of fluids to the patient with the potential to cause patient injury or d ... Read on »
Class I Medical Device Recall: CareFusion Alaris Syringe Pump Alarm Error May Cause Interruption... by FDA Posted in: Blog Posts in Health Education An error in the syringe pump triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. Even when the user clears the error code ... Read on »
General Mills voluntarily recalls a limited quantity of frozen Cascadian Farm Cut Green Beans by FDA Posted in: Blog Posts in Health Education General Mills today announced a voluntary Class I recall of a limited quantity of frozen Cascadian Farm Cut Green Beans produced over two days in March 2014. The recall is ... Read on »
Recall Sam Mills Gluten Free Chocolate Chip Granola Bar by FDA Posted in: Blog Posts in Health Education Sam Mills USA LLC is voluntarily recalling approximately 11,083 cases of - 4.4 ounce boxes of Gluten Free Chocolate Chip Granola Bars because of a risk of cross contaminatio ... Read on »
Sid Wainer and Son Recalls Jansal Valley Raw Macadamia Nuts Due to Possible Health Risk by FDA Posted in: Blog Posts in Health Education Sid Wainer and Son of New Bedford, MA is voluntarily recalling Jansal Valley brand Raw Macadamia Nuts, because it has the potential to be contaminated with Salmonella, an or ... Read on »
Novacare, LLC Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared... by FDA Posted in: Blog Posts in Health Education Novacare, LLC of Murray, Utah is voluntarily recalling all lots of the following dietary supplements to the consumer level Read on »
Class I Medical Device Recall: Teleflex Medical, Hudson RCI Sheridan Sher-I-Bronch Endobronchial... by FDA Posted in: Blog Posts in Health Education Teleflex Medical has received customer complaints about the endobroncial tube’s double swivel connector. The connector may break or separate on the tube. If this happens, ... Read on »
Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of... by FDA Posted in: Blog Posts in Health Education This special controls guideline was developed to support the classification of a Clostridium difficile toxin gene amplification assay into class II (special controls). Read on »
Jo’s Candies Issues Voluntary Alert on Undeclared Milk in by FDA Posted in: Blog Posts in Health Education Jo’s Candies of Torrance, California is voluntarily recalling Trader Joe’s Dark Chocolate covered Honey Grahams with Sea Salt (SKU 55024), because it may contain milk, which ... Read on »
Public Workshop - In Vitro Diagnostic Testing for Direct Oral Anticoagulants, October 26, 2015 by FDA Posted in: Blog Posts in Health Education The Food and Drug Administration (FDA) is announcing a public workshop entitled “In Vitro Diagnostic Testing for Direct Oral Anticoagulants”. The objective of the worksh ... Read on »
Federal Register: Medical Device Epidemiology Network Registry Task Force Report; Availability,... by FDA Posted in: Blog Posts in Health Education The FDA is announcing the availability of the report and Web site location where the Agency has posted the report ``Recommendations for a National Medical Device Evaluation ... Read on »
Allergan Issues Voluntary Nationwide Recall In The U.S. Of Specific Lots Of REFRESH®... by FDA Posted in: Blog Posts in Health Education Allergan plc, today announced that it is conducting a voluntary recall down to consumer level of specific lots of its REFRESH® Lacri-Lube® 3.5g and 7g for dry eye, REFRESH P ... Read on »
Recommendations for a National Medical Device Evaluation System: Strategically Coordinated... by FDA Posted in: Blog Posts in Health Education In June 2014 two parallel groups were tasked with providing recommendations to FDA toward development of a national medical device system that could both support better regu ... Read on »
Chetak New York L.L.C. Recalls 14.1 oz. Jar of "Deep Coriander Powder" Because of Possible Health... by FDA Posted in: Blog Posts in Health Education Chetak New York L.L.C. of Edison, NJ is recalling 300 jars of 14.1oz "Deep Coriander Powder", Lot# LE15152, because they have the potential to be contaminated with Salmonell ... Read on »