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 Intuitive Surgical has issued a letter to affected customers recommending certain curved-tip staplers be…

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 Insulet has issued a letter to affected customers recommending certain Omnipod 5 Pods be…

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 updating instructions for affected devices, and does not involve removing them from where they are used or…

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 certain devices from where they are used or sold. Affected Product The FDA is aware that…

Summary Company Announcement Date: March 12, 2026 FDA Publish Date: March 13, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Pods may have a small tear in the internal tubing that delivers insulin. This may leak inside the Pod instead of being fully infused into the body as intended. Company Name: Insulet…

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 Erbe USA has issued a letter to affected customers recommending certain Erbe Flexible Cryprobes…

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.  This is an expansion of a previous recall. Affected Product The FDA is aware that Medline Industries…

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 certain devices from where they are used or sold.  Affected Product The FDA is aware that…

The affected products 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. Medline Industries has issued an expansion to this recall. Affected Product…

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…