Date Issued: April 28, 2026 The U.S. Food and Drug Administration (FDA) is alerting consumers and health care providers of risks involved with the use of TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health. Trividia Health has issued a recall that affects all TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO Self-Monitoring Blood…
Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems
This recall is an update to an Early Alert. The FDA has identified this recall as Class I, the most serious type. This device may cause serious injury or death if the recommendations below are not followed. Affected Product The FDA is aware that Trividia Health, Inc. has issued an Urgent Medical Device Correction to notify affected customers…
B. Braun Medical, Inc. Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection, 1L, E7500 Due to the Presence of Particulate Matter in Solution
Summary Company Announcement Date: April 28, 2026 FDA Publish Date: April 28, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to contain particulate matter in solution Company Name: B. Braun Medical Inc. Brand Name: Brand Name(s) Product Description: Product Description Lactated Ringer’s Injection, E7500, 1L Company Announcement For Immediate Release…
Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods
The affected product lots and information about the issue below have changed. This recall involves removing certain 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 What to Do Do not use affected Pods. If you…
Ghirardelli Chocolate Company Recalls Powdered Beverage Mixes Because of Possible Health Risk
Summary Company Announcement Date: April 27, 2026 FDA Publish Date: April 28, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Salmonella Company Name: Ghirardelli Chocolate Company Brand Name: Brand Name(s) Ghirardelli Product Description: Product Description Powdered beverage mixes Company Announcement Ghirardelli Chocolate Company of San…
Early Alert: Thoracic Stent Graft Issue from Bolton Medical
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 Bolton Medical has issued an Urgent Medical Device Recall (Correction) notice providing updated use…
We R Nuts, Issues Allergy Alert on Undeclared Milk, Soy & Cashews in Milk Chocolate Bridge Mix
Summary Company Announcement Date: April 24, 2026 FDA Publish Date: April 27, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May contain undeclared milk, soy, and cashews Company Name: We R Nuts, LLC. Brand Name: Brand Name(s) Uncle Giuseppe’s Product Description: Product Description Chocolate covered nuts and raisins Company Announcement…
Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers
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 Arrow International has issued a letter to affected customers recommending dialysis catheter kits containing…
Early Alert: Automated Compounding System Issue from Omnicell
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 Omnicell has issued a letter to affected customers recommending certain syringe labels used with…
French Broad Chocolates PBC Recalls Bette’s Bake Sale Bonbons Due to Undeclared Walnuts
Summary Company Announcement Date: April 23, 2026 FDA Publish Date: April 24, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Tree Nuts Company Name: French Broad Chocolate Factory Brand Name: Brand Name(s) French Broad Chocolate Product Description: Product Description Bette’s Bake Sale Bonbon Collection in 6pc (2.5oz), 12pc (5oz),…