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 Abiomed has…

AUDIENCE: Consumer, Patient, Health Care Provider, Pharmacy, Gastroenterology, Nephrology, Endocrinology ISSUE: The FDA has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to…

Summary Company Announcement Date: June 06, 2026 FDA Publish Date: June 08, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides Company Name: BD Brand Name: Brand Name(s) Product Description: Product Description ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP…

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 Hamilton Medical has issued a letter to affected customers recommending certain coaxial breathing circuit…

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 GE HealthCare has issued a letter to affected customers recommending Infant Resuscitation Systems and…

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…