Summary Company Announcement Date: June 04, 2026 FDA Publish Date: June 04, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential chemical contamination Company Name: Haleon Brand Name: Brand Name(s) Product Description: Product Description Gass-X Extra Strength Softgels 120 and 72ct Company Announcement WARREN, N.J., June 4, 2026 — Haleon (NYSE: HLN) is…

This recall involves correcting certain devices and does not involve removing them 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 without correction. Affected Product Bupivacaine Ampule Example kit with Bupivacaine ampule…

Date Issued: June 3, 2026 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers of the elevated long-term risk of device failure, higher-than-expected risk of revision surgery, and risk of polyethylene fracture (plastic breakage) observed in the Hintermann Series H3 Total Ankle Replacement (TAR) System (also referred to as…

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 Abiomed has issued a letter to affected customers recommending all 14Fr Low Profile Introducer…

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. The affected products and recommendations for what to do with the devices below have not changed. Affected…

Summary Company Announcement Date: May 26, 2026 FDA Publish Date: May 29, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Sensors identified as scrap were diverted and sold by third-party Company Name: Dexcom, Inc. Brand Name: Brand Name(s) Product Description: Product Description Continuous Glucose Monitoring System Company Announcement Through ongoing quality and…

This recall involves correcting certain devices, and does not involve removing them 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 without correction.   Affected Product The FDA is aware that KayserBetten has issued a letter to affected customers recommending…

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 FDA is aware that Medline has issued a letter to affected customers recommending certain…

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 ICU Medical has issued a customer communication recommending certain IV tubing sets be removed…

Summary Company Announcement Date: May 26, 2026 FDA Publish Date: May 26, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Manufacturing issue that could result in under delivery of insulin Company Name: Insulet Corporation, Inc. Brand Name: Brand Name(s) Product Description: Product Description Device intended for the subcutaneous delivery of insulin into…