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 Baxter has issued an Urgent Medical Device Correction notice to affected customers recommending all…

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 Medline…

Summary Company Announcement Date: June 11, 2026 FDA Publish Date: June 12, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Above acceptable microbiological limits for yeast and may contain Aspergillus spp. Company Name: Beekeeper’s Naturals Brand Name: Brand Name(s) Beekeeper’s Naturals Product Description: Product Description Saline Nasal Spray Company Announcement FOR IMMEDIATE RELEASE…

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…