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 Stellar Non-invasive and Invasive Ventilators Model Numbers: 100 and 150 with serial number range: 20160123307 to 22171057208 Manufacturing Dates: April 2016 to June 2017 Distribution Dates: April…
Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters
Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 20, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Catheter balloon may not deflate as intended Company Name: Abbott Brand Name: Brand Name(s) Product Description: Product Description Coronary dilatation catheters Company Announcement Abbott has voluntarily recalled specific lots of two catheters…
Natural Grocers Issues Recall on Dark Chocolate Peanut Clusters
Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 20, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared almonds Company Name: Vitamin Cottage Natural Food Markets, Inc. Brand Name: Brand Name(s) Natural Grocers Product Description: Product Description Peanut clusters dark chocolate Non GMO Company Announcement Vitamin Cottage Natural…
Natural Grocers Issues Recall on Dark Chocolate Almond Clusters
Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 20, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Peanut clusters dark chocolate Non GMO Company Name: Dr. Praeger’s Sensible Foods, Inc. Brand Name: Brand Name(s) Natural Grocers Product Description: Product Description Almond clusters dark chocolate Non GMO Company Announcement…
Moonstruck Chocolate Issues Allergy Alert on Undeclared Milk in 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate
Summary Company Announcement Date: February 21, 2020 FDA Publish Date: February 21, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Moonstruck Chocolate Co. Brand Name: Brand Name(s) Moonstruck Product Description: Product Description Praline Pecan & Ginger Element Bar in Dark Chocolate Company Announcement Moonstruck Chocolate Co. of…
Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing
Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 21, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Possible underdosing or overdosing Company Name: Taro Pharmaceuticals U.S.A., Inc. Brand Name: Brand Name(s) Taro Pharmaceuticals U.S.A., Inc. Product Description: Product Description Phenytoin Oral Suspension USP, 125 mg/5 mL Company Announcement Taro Pharmaceuticals…
Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate
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: NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation CathetersModels: Balloon diameters 4.0mm, 4.5mm and 5.0mmLots: See a full list of affected devices Distribution…
Saratoga Potato Chips, LLC Issues Allergy Alert on Undeclared Milk in Kroger Sweet & Mesquite BBQ Potato Chips
Summary Company Announcement Date: February 19, 2020 FDA Publish Date: February 19, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Saratoga Potato Chips, LLC Brand Name: Brand Name(s) Product Description: Product Description Sweet & Mesquite BBQ Potato Chips Company Announcement Saratoga Potato Chips, llc of Fort Wayne,…
Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway
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 Name and Version: COMFORT FLO Humidification System, REF 2410, Humidifier Nebulizer Kit Product Code: GTIN 14026704659347 Name and Version: COMFORT FLO Humidification System with Remote Temperature Port,…
Fighting Diabetes’ Deadly Impact on Minorities
Español You inherit more than your eye and hair color from your family. You can also inherit a predisposition for diabetes, a disease that disproportionally affects racial and ethnic minorities. The Office of Minority Health (OMH) at the Food and Drug Administration (FDA) is building relationships with the American Diabetes Association (ADA) and other groups…