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 Edwards Lifesciences has issued a letter to affected customers recommending certain delivery systems used…
Pan Pepín Inc. Emite Alerta por Alérgenos en el Producto Parabien al Grano Debido a la Presencia de Sésamo No Declarado
Summary Company Announcement Date: October 13, 2026 FDA Publish Date: October 14, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared sesame Company Name: Pan Pepin Inc. Brand Name: Brand Name(s) Product Description: Product Description Para Bien Al Grano Company Announcement Bayamón, Puerto Rico – Pan Pepín Inc., con sede…
Krasnyi Oktyabr Inc. Recalls Starfish Seafood Premium Cold Smoked Norwegian Salmon Sliced (227g/8oz) Because of Possible Health Risk
Summary Company Announcement Date: October 09, 2026 FDA Publish Date: October 09, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: Krasnyi Oktyabr Inc. Brand Name: Brand Name(s) Starfish Seafood Product Description: Product Description Cold Smoked Salmon Company Announcement “This is…
Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O157:H7 Contamination
Summary Company Announcement Date: October 15, 2026 FDA Publish Date: October 15, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Shiga toxin-producing Escherichia coli (E. Coli O157:H7) Company Name: Family Farmstead Dairy, LLC Brand Name: Brand Name(s) Family Farmstead Product Description: Product Description Raw…
Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
The affected products and recommendations for what to do with the devices below have not 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…
Pan Pepin Inc. Issues Allergy Alert of Para Bien Al Grano Due to Undeclared Sesame
Summary Company Announcement Date: October 13, 2026 FDA Publish Date: October 14, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared sesame Company Name: Pan Pepin Inc. Brand Name: Brand Name(s) Product Description: Product Description Para Bien Al Grano, 24oz box Company Announcement Pan Pepin Inc. of Bayamón, Puerto Rico…
Convenience Kit Recall: Medline Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
The affected products and recommendations for what to do with the devices below have not 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…
Early Alert: Diagnostic Ultrasound System Issue from Philips Ultrasound
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. The FDA is aware that Philips Ultrasound has issued a letter to affected customers recommending all Lumify diagnostic ultrasound systems…
Krasnyi Oktyabr Inc. Recalls Starfish Seafood Trio Because of Possible Health Risk
Summary Company Announcement Date: October 09, 2026 FDA Publish Date: October 09, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: Krasnyi Oktyabr Inc. Brand Name: Brand Name(s) Starfish Seafood Product Description: Product Description Cold Smoked Salmon, Halibut, and Trout Company…
Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter
Summary Company Announcement Date: October 08, 2026 FDA Publish Date: October 09, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified as cellulose Company Name: Par Health Brand Name: Brand Name(s) Par Pharmaceutical Product Description: Product Description Brevital Sodium 500 mg/vial for Injection Company Announcement FOR IMMEDIATE RELEASE –…