Date Issued: April 24, 2025 The U.S. Food and Drug Administration (FDA) is alerting health care providers and laboratory staff of reports that falsely elevated (false positive) results have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems. These tests may overestimate blood lead levels and…

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 Product Names: HeartMate Mobile Power Unit (MPU) used with the HeartMate 3 Left Ventricular Assist…

Summary Company Announcement Date: April 18, 2025 FDA Publish Date: April 18, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Distal Tip Design outside scope of 510k clearance Company Name: Q’Apel Medical, Inc. Brand Name: Brand Name(s) Q’Apel Medical Product Description: Product Description 072 Aspiration System Company Announcement Fremont, CA – April…

Summary Company Announcement Date: April 18, 2025 FDA Publish Date: April 18, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Product may contain an inert fiber identified as polypropylene fibers from the IV bag Company Name: Amneal Pharmaceuticals LLC. Brand Name: Brand Name(s) Amneal Pharmaceuticals LLC. Product Description: Product Description Ropivacaine Hydrochloride Injection,…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware 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 Conavi has issued a…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware 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 BD and their subsidiary…

Summary Company Announcement Date: April 03, 2025 FDA Publish Date: April 07, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Increased frequency of reports of toxic anterior segment syndrome Company Name: Bausch + Lomb Corporation Brand Name: Brand Name(s) enVista Aspire Product Description: Product Description enVista Aspire™, enVista Envy™ and Certain enVista®…

Summary Company Announcement Date: April 07, 2025 FDA Publish Date: April 07, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Expanded recall due to potential safety and performance concerns Company Name: Max Mobility, LLC. Brand Name: Brand Name(s) Max Mobility/Permobil Product Description: Product Description Speed Control Dial Component Company Announcement FOR IMMEDIATE…

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 Product Names:  DLP Aortic Root Cannula  MiAR Cannula DLP Aortic Root Cannula with Vent Line…

UPDATE: March 2025 The FDA is providing an update that Megadyne has communicated in a letter the availability of a labeling (pad printing) update for Megadyne Mega Soft Universal (0845 & 0846) and Universal Plus (0847 & 0848) Reusable Patient Return Electrodes. The pad printing will now show the updated indication which is for patients…