Early Alert: Catheter Introducer Issue from Abiomed and Oscor

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 Abiomed and its manufacturing partner Oscor have issued a letter to affected customers recommending all Introducer…

Early Alert: Convenience Kit Issue from Windstone Medical Packaging, Inc.

Component Name Cardinal Health Part Number Aligned Medical Solutions Part Number Component Lot Number Webcol Large Alcohol Prep Pad 5110 69124 25K006462 Full List of Affected Products What to Do Apply the Aligned Medical Solutions over-label (see Recall Notice image below) to affected inventory. When the affected convenience kits are opened for use, remove, discard and do not…

Disruptions in Availability of Breast Biopsy Needles – Letter to Health Care Providers

June 16, 2026 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of stereotactic breast biopsy needles because of recent supplier issues. The manufacturing disruption in supply of these devices is expected to impact patient care and may require adjustments to the clinical management of patients…

Early Alert: Positive Pressure Breathing Device Issue from Baxter

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…

Beekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial Contamination

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…