This is an update to an Early Alert. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The reason for recall has been updated for clarity; the affected products…
Early Alert: Heart Pump Controller Purge Cassette Issue from Abiomed
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 has issued a letter to affected customers recommending all Automated Impella Controllers be removed from…
Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing BD ChloraPrep Applicators
The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The affected products have been updated. Recommendations for what to do with the devices below have not…
Breathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing Circuits
The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. The affected products and recommendations for what to do with the devices below have not changed. This recall involves removing devices from where they are used or sold. Affected Product The FDA is aware that Medline…
Ana Salazar Modela Tu Cuerpo Inc. Issues Nationwide Voluntary Recall of Lipofit Extreme Fat Burner 2.0 Due to Presence of Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
Summary Company Announcement Date: August 27, 2026 FDA Publish Date: August 31, 2026 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP) Company Name: Ana Salazar Modela Tu Cuerpo Inc. Brand Name: Brand Name(s) Product Description: Product Description Lipofit Extreme 2.0 Fat Burner Dietary Supplement Company Announcement FOR IMMEDIATE…
Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging
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 Medtronic and their subsidiary Given Imaging, Inc. have issued a letter to affected customers recommending…
B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter
Summary Company Announcement Date: August 27, 2026 FDA Publish Date: August 28, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified as iron oxide Company Name: B. Braun Medical Inc. Brand Name: Brand Name(s) Product Description: Product Description 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL…
Early Alert: Angiographic Catheter Issue from Boston Scientific
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 Boston Scientific has issued a letter to affected customers recommending all Imager II…
Early Alert: IV Start Kit Issue from Avid Medical
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 Avid Medical has issued a letter to affected customers recommending certain convenience kits affected…
Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle Manifolds
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 AVID Medical…