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MedWatch Safety Alert

Smiths Medical Issues Worldwide Notification Regarding the Recall of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe With Skewed Graduation Markings

Smiths Medical has become aware of specific models and lots of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. Markings skewed approximately 20 degrees upward have been identified.


2021 Medical Device Recalls

List of Medical Device recalls in 2021.


Infusion Pump Repair Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts

Bezel posts on the Alaris Infusion Pump Module 8100 are critical to pump function. Infusion Pump Repair bezel posts may crack or separate.


Philips Issues a Recall Notification* to Mitigate Potential Health Risks Related to the Sound Abatement Foam Component in Certain Sleep and Respiratory Care Devices

Following the company update on April 26, 2021, Royal Philips(NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address ide


Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level.


2021 Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.


Sodium Citrate Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel

Sodium Citrate Blood Specimen Collection Tube Conservation Strategies


Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results

Innova SARS-CoV-2 Antigen Rapid Qualitative Test performance characteristics have not been adequately established, presenting a risk of false results.


Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication

The FDA has significant concerns that performance of the test has not been adequately established, presenting a risk to health.