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…
Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Tandem Mobi Insulin Pumps
This recall involves correcting 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. This recall was classified on November 5, 2025. Affected Product…
Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Namic Angiographic Rotating Adapter 10CC Control Syringe Placed into the Following Kits; AMS6908E Angio Pack, and AMS6908F Angio Pack
Summary Company Announcement Date: April 16, 2026 FDA Publish Date: April 20, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold, potentially causing biohazard exposure, blood loss, infection, or…
Anesthesia Workstation Correction: Draeger Issues Correction for Atlan A350 and A350 XL
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. This recall was classified on October 1, 2025. …
Ventilator Tubing Correction: Percussionaire Corporation Updates Use Instructions for Phasitron In-Line Valve
This recall involves updating instructions for using 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 following the updated instructions. This recall was classified…
Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators
This recall involves correcting 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 Philips has issued…
Early Alert: Convenience Kit Issue from American Contract Systems
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 American Contract Systems has issued a letter to affected customers recommending certain angiographic…
Early Alert: Convenience Kit Issue from Medical Action Industries
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 Medical Action Industries has issued a letter to affected customers recommending certain angiographic syringes…
Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants
This recall involves correcting devices 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 The FDA is aware that Stryker has issued letters to affected customers recommending certain TMJ Unilateral…