[Posted 05/12/2025] AUDIENCE: Patient, Health Care Professional, Pharmacy ISSUE: The FDA and the CDC are recommending a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while the Agencies investigate postmarketing reports of serious adverse events, including neurologic and cardiac events, in individuals who have received the vaccine….
EnShiShiXiangNiShangMaoYouXianGongSi Issues Voluntary Nationwide Recall of ENDURANCE BOOST WITH HORNY GOAT WEED Capsules Due To Presence of Undeclared Propoxyphenylsildenafil and Sildenafil
Summary Company Announcement Date: May 06, 2025 FDA Publish Date: May 06, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Propoxyphenylsildenafil, Sildenafil Company Name: EnShiShiXiangNiShangMaoYouXianGongSi Brand Name: Brand Name(s) Endurance Boost Product Description: Product Description Dietary supplement for male performance and energy Company Announcement EnShiShiXiangNiShangMaoYouXianGongSi is voluntarily recalling one lot of ENDURANCE…
Risk of False Positive Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication
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…
Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss
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…
FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I
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…
Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate Matter
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,…
Early Alert: Diagnostic Intravascular Catheter Issue from Conavi
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…
Early Alert: Intravascular PICC Catheter Issue from BD
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…
Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses in the U.S.
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®…
Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User
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…