B. Braun Medical, Inc. Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection, 1L, E7500 Due to the Presence of Particulate Matter in Solution

Summary Company Announcement Date: April 28, 2026 FDA Publish Date: April 28, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to contain particulate matter in solution Company Name: B. Braun Medical Inc. Brand Name: Brand Name(s) Product Description: Product Description Lactated Ringer’s Injection, E7500, 1L Company Announcement For Immediate Release…

Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods

The affected product lots and information about the issue below have changed. 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 What to Do Do not use affected Pods. If you…

Early Alert: Thoracic Stent Graft Issue from Bolton 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 Bolton Medical has issued an Urgent Medical Device Recall (Correction) notice providing updated use…

Early Alert: Automated Compounding System Issue from Omnicell

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 Omnicell has issued a letter to affected customers recommending certain syringe labels used with…

Early Alert: Convenience Kit Issue from Aligned Medical Solutions

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 Aligned Medical Solutions has issued a letter to affected customers recommending certain angiographic syringes…