Summary Company Announcement Date: October 13, 2026 FDA Publish Date: October 14, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel Company Name: Par Health USA, LLC Brand Name: Brand Name(s) Par Health and Endo USA Product Description:…

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…

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…

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…

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…

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 –…

Summary Company Announcement Date: October 05, 2026 FDA Publish Date: October 06, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Software issue may cause a glucose result to be associated to the wrong patient Company Name: Nova Biomedical Brand Name: Brand Name(s) Nova Biomedical StatStrip Product Description: Product Description StatStrip Glucose Hospital…

The affected products and recommendations for what to do with the devices 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…

The affected products and recommendations for what to do with the devices below have changed. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. Affected Product The FDA is aware that ICU Medical has issued a customer communication recommending updated use instructions for certain IV…

Summary Company Announcement Date: September 07, 2026 FDA Publish Date: September 08, 2026 Product Type: Medical Devices 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…