Image Español Braces have come a long way, and there are now more options than ever in both style and materials. Braces, clear dental aligners, and other orthodontic devices are medical devices, which means the FDA regulates them. Before companies can market these products in the United States, companies must meet the applicable legal requirements…
Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead
This recall involves removing unused devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Figure 1. Infinion CX Lead The FDA is aware that Boston Scientific has issued…
BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect
Summary Company Announcement Date: September 07, 2026 FDA Publish Date: September 08, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect Company Name: BMC Medical Co., Ltd. Brand Name: Brand Name(s) Product Description: Product Description Luna G3…
FreshPoint Issues Recall Due to an Improperly Declared Allergen (Egg) in Chicken Salad Wedge Sandwiches
Summary Company Announcement Date: September 08, 2026 FDA Publish Date: September 08, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Improperly declared egg allergen Company Name: FreshPoint Central Florida, Inc. Brand Name: Brand Name(s) Created Fresh! Product Description: Product Description Cranberry Chicken Salad Wedge Sandwich Company Announcement September 4, 2026…
Made Fresh Salads, Inc. Recalls Ready to Eat Deli Style Salads and Cream Cheese Because of Possible Health Risk
Summary Company Announcement Date: September 06, 2026 FDA Publish Date: September 06, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: Made Fresh Salads Inc. Brand Name: Brand Name(s) Made Fresh Salads, Northside Product Description: Product Description Ready to Eat Deli Style Salads…
Early Alert: Breathing Circuit Issue from Draeger
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Draeger has issued a letter to affected customers recommending certain VentStar Resus Neo hoses…
Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software
This is an update to an Early Alert. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The reason for recall has been updated for clarity; the affected products…
SUPPLX.com Issues Voluntary Nationwide Recall of Business Pill and Branch Manager for Men Due to Undeclared Yohimbine
Summary Company Announcement Date: September 03, 2026 FDA Publish Date: September 04, 2026 Product Type: Dietary SupplementsFood & Beverages Reason for Announcement: Recall Reason Description Products contain undeclared yohimbine Company Name: SUPPLX.com Brand Name: Brand Name(s) Business Pill, Branch Manager for Men Product Description: Product Description dietary supplements marketed for male sexual enhancement Company Announcement…
American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility
Summary Company Announcement Date: September 03, 2026 FDA Publish Date: September 03, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Presence of particulate matter and lack of sterility assurance Company Name: American Regent, Inc. Brand Name: Brand Name(s) American Regent, Inc. Product Description: Product Description Epinephrine Injection, USP 30 mg/ 30…
Foods Alive Recalls Organic Moringa Leaf Powder Because of Possible Health Risk
Summary Company Announcement Date: September 04, 2026 FDA Publish Date: September 04, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Foods Alive Inc. Brand Name: Brand Name(s) Foods Alive Product Description: Product Description Moringa Leaf Powder Company Announcement Foods Alive Inc…