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. Please be aware, this recall is a voluntary correction, not a product removal. Eitan Medical Ltd will be updating affected devices to address this issue. Recalled Product: Product Name:…
Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
Date Issued: November 30, 2023 The U.S. Food and Drug Administration (FDA) is informing consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China. The FDA is collecting and analyzing data to evaluate plastic…
Bix Produce Issues Safety Alert on Cut Cantaloupe Products Due to Potential Salmonella Contamination
Summary Company Announcement Date: November 28, 2023 FDA Publish Date: November 30, 2023 Product Type: Food & Beverages Fruit/Fruit Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential for Salmonella contamination Company Name: Bix Produce Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Fruit Cups containing cantaloupe Company Announcement Little Canada, MN.,…
Gaws Gourmet Foods Issues Allergy Alert on Undeclared Sesame in Sandwiches
Summary Company Announcement Date: November 30, 2023 FDA Publish Date: November 30, 2023 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared sesame Company Name: Gaws Gourmet Foods Brand Name: Brand Name(s) Product Description: Product Description Deli sub and breakfast bagel sandwiches Company Announcement Gaws Gourmet Foods of Marysville, MI, is…
Meta Herbal Issues Voluntary Nationwide Recall of Magnum XXL 9800 Capsules Due to Presence of Undeclared Sildenafil
Summary Company Announcement Date: November 29, 2023 FDA Publish Date: November 29, 2023 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil Company Name: Meta Herbal Brand Name: Brand Name(s) Product Description: Product Description Magnum Male Sexual Enhancement XXL 9800 capsule Company Announcement FOR IMMEDIATE RELEASE – November 28, 2023 – E….
Doctors Scientific Organica Announces Voluntary Recall of Limited Quantity of Burn Boot Camp Afterburn Grass-Fed Whey Protein Bars (60 grams) Due to Potential Presence of Foreign Material
Summary Company Announcement Date: November 28, 2023 FDA Publish Date: November 29, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of foreign material Company Name: Doctors Scientific Organica Brand Name: Brand Name(s) Burn Boot Camp Product Description: Product Description Triple Chocolate Almond Flavored Whey Protein Bars Company Announcement Riviera…
GHGA, LLC, in Coordination with Sofia Produce, LLC DBA Trufresh, Voluntarily Recalls Select Fresh-Cut Fruit Products Due to Possible Salmonella Contamination
Summary Company Announcement Date: November 29, 2023 FDA Publish Date: November 29, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: GHGA, LLC Brand Name: Brand Name(s) Sprouts Farmers Market, Trader Joe’s, None Product Description: Product Description Fruit cups and trays containing cantaloupe. Company…
Braces Have Changed, From Metal to Tooth-Colored to Clear
[embedded content] Español Your dentist tells you that you need braces, bringing back not-so-fond memories of kids being called “Metal Mouth.” Take heart. Braces have evolved over the years and new alternatives in both look and materials are available. FDA is responsible for reviewing these devices for safety and effectiveness and, as appropriate, granting marketing…
Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication
Date Issued: November 28, 2023 The U.S. Food and Drug Administration (FDA) is warning patients and health care providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The FDA recently received medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs…
Whole Genome Sequencing: Cracking the Genetic Code for Foodborne Illness
Image A person commits a crime, and the detective uses DNA evidence collected from the crime scene to track the criminal down. An outbreak of foodborne illness makes people sick, and the U.S. Food and Drug Administration (FDA) uses DNA evidence to track down the bacteria that caused it. Sound far-fetched? It’s not. The FDA…