MedWatch Safety Alerts

Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform

Balt USA is removing their Mega Ballast because of the unintended presence of loose hydrophilic coating inside the tube at the tip end

Recall Alert: Baxter Permanently Removes Life2000 Ventilation System

Baxter is permanently removing all Life2000 Ventilation Systems after discovering a cybersecurity issue that may allow unauthorized access to the device

Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices

SpeedControl Dials used with SmartDrive MX2+ Power Assist Devices may be unresponsive to users and fail to stop or start unexpectedly, causing injury

Early Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue from Fresenius Kabi

Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications

Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended

Recall Alert: Intersurgical Inc Removes i-View Video Laryngoscope

Intersurgical is recalling the i-View Video Laryngoscope due to the device not turning on, battery liquid leakage and screen going blank

Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Rapid Command Input Issue

If a user rapidly presses two or more on-screen buttons, the NOxBOXi Nitric Oxide Delivery System may experience sudden software interruption or restart

Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits

Medline is recalling certain Convenience Kits due to being labeled as sterile but not having gone through the sterilization process

Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk for Nitric Oxide Dosing Fluctuations

There may be nitric oxide dosing fluctuations and therapy interruption when NOxBOXi Nitric Oxide Delivery System is used with certain ventilators

Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems

Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system

Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System

Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols - FDA Safety Communication

These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices

Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples

FOR IMMEDIATE RELEASE – Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical

Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20

Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers

Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices; asks for reports of injuries related these devices

Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller

FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI

Trividia Health, Inc. Initiates Voluntary Recall of Limited Number of TRUE METRIX® Blood Glucose Meters

(FT. LAUDERDALE, FL) –October 7, 2025 – Trividia Health, Inc., announced today that it is initiating a voluntary recall of a limited number of TRUE METRIX® Self-Monitoring Blood