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 Cook Medical Fixed Core Wire Guide Affected Models: o Model TSCF-35-260-3 Lots: Manufacturing Dates: August 24, 2020 Distribution Dates: September 09, 2020 Devices Recalled in the U.S.:…
Protect Your Family From Fraudulent Flu Products
Image The fall and winter flu season may bring out dishonest sellers hawking fraudulent products to unsuspecting consumers, who are already concerned about protecting themselves from coronavirus disease 2019 (COVID-19) and other infectious diseases. Some of these sellers offer unproven products that claim to prevent, mitigate, treat, or cure the flu even though they have…
Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination
Summary Company Announcement Date: November 09, 2020 FDA Publish Date: November 09, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description May be contaminated with Burkholderia lata Company Name: Lohxa, LLC Brand Name: Brand Name(s) Product Description: Product Description Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free Company Announcement Lohxa, LLC is voluntarily recalling…
Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use
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 Trevo XP ProVue Retriever Catalog Numbers and Lot Numbers: Full List of Affected Devices Manufacturing Dates: July 22, 2019 to September 9, 2019 Distribution Dates: September 18,…
Tanimura & Antle Voluntary Recalls Packaged Single Head Romaine Lettuce Due to Potential E. Coli 0157:H7 Contamination
Summary Company Announcement Date: November 06, 2020 FDA Publish Date: November 06, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Possible contamination with E. Coli 0157:H7 Company Name: Tanimura & Antle Inc. Brand Name: Brand Name(s) Tanimura & Antle Product Description: Product Description Single head romaine lettuce Company Announcement Out of…
Coronavirus Disease 2019 Testing Basics
Español 简体中文 한국어 Tagalog Việt You’ve probably heard a lot about coronavirus disease (COVID-19) testing recently. If you think you have COVID-19 and need a test, contact your health care provider, local pharmacy, or local health department immediately. The FDA has been working around the clock to increase the availability of critical medical products, including…
Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues
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 Rashkind Balloon Septostomy Catheter Lot Numbers: See the Recall database entries below for lot numbers Product Numbers: 008764, 007160, and 007161 Distribution Dates: May 28, 2018 to…
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Summary Company Announcement Date: November 02, 2020 FDA Publish Date: November 03, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily intake limit Company Name: Nostrum Laboratories Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Metformin HCl Extended Release Tablets, USP 500 mg Company Announcement Nostrum Laboratories, Inc….
Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 – Letter to Clinical Laboratory Staff and Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. Generally, antigen tests are indicated for the qualitative detection of SARS-CoV-2…
Natural Grocers Issues Voluntary Recall on Organic Elderberries Due to Potential Presence of Salmonella
Summary Company Announcement Date: October 29, 2020 FDA Publish Date: November 02, 2020 Product Type: Food & Beverages Fruit/Fruit Product Foodborne Illness Reason for Announcement: Recall Reason Description Salmonella Company Name: Vitamin Cottage Natural Food Markets, Inc. Brand Name: Brand Name(s) Natural Grocers Product Description: Product Description Organic Whole Elder Berries Company Announcement Vitamin Cottage…