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 update to an Early Alert; the affected products have not changed. Recommendations for what…

May 6, 2026 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of neurosurgical patties, sponges and strip devices 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…

Summary Company Announcement Date: May 01, 2026 FDA Publish Date: May 05, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high…

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 updated Early Alert. The affected products and recommendations for what to do with the…

Date Issued: April 28, 2026 The U.S. Food and Drug Administration (FDA) is alerting consumers and health care providers of risks involved with the use of TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health. Trividia Health has issued a recall that affects all TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO Self-Monitoring Blood…

This recall is an update to an Early Alert. The FDA has identified this recall as Class I, the most serious type. This device may cause serious injury or death if the recommendations below are not followed.   Affected Product The FDA is aware that Trividia Health, Inc. has issued an Urgent Medical Device Correction to notify affected customers…

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…

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…

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…

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 Arrow International has issued a letter to affected customers recommending dialysis catheter kits containing…