These vascular embolization devices’ instructions for use have been updated by Boston Scientific.

MiniMed pumps deliver insulin to people with diabetes who need it. Wiring damage from impacts may cause the battery to drain faster than expected.

10/8/24 – National City, CA, C&A Naturistics is voluntarily recalling all lots of AK Forte, 400 mg tablets, to the consumer level. FDA analysis has found the product to be tainted Diclofenac, Dexamethasone, and Methocarbamol. Products containing diclofenac, dexamethasone, and methocarbamol cannot b

Bennet, NE, STASKA PHARMACEUTICALS, INC. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch.

The FDA issues alert about risk of false results with Cue Health’s COVID-19 Tests due to modifications made without FDA authorization that have a strong likelihood to impact performance.

Zyno Medical Z-800 infusion pumps allow for infusions through the blood vessels but a software defect may allow air bubbles to enter the patient.

The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy.

Neo-Tee Resuscitators are used for emergency breathing support for neonates and infants. The inline controller may come apart and impact ventilation.

IPV Phasitron 5 In-Line Valve helps provide therapy to promote ventilation. Users need to remove the expiratory port plug before direct ventilation.

Trilogy Evo, EV300, EvoO2 and Evo Universal ventilators support patient breathing. A mandatory software correction was issued to address previously reported issues.

Ivenix LVP allows for controlled administration of large volumes of fluids but software anomalies may lead to delay or underdosing of therapy.

paraPAC Plus P300 and P310 Ventilators are gas-powered emergency and transport portable ventilators. The tidal volume knob may move out of the set position.

Automated Compounding Device Inlets used with Exactamix Compounding Devices may contain particulate matter that poses a risk to patients.

Foster City, Calif., September 20, 2024 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in

paraPAC Plus P300 and P310 are emergency and transport portable ventilators. The patient outlet connector may be loose or detached, impacting ventilation.

Bivona tracheostomy tubes provide a secure airway in pediatric and adult patients. A manufacturing defect may lead to a tear in the tube’s flange.

September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be con

Infusomat Space Infusion Systems deliver fluids, blood, and blood products. The occlusion alarm may sound when there is no occlusion, leading to delayed therapy.

Read the FDA’s recommendations related to the Zimmer Biomet CPT Hip System and increased risk of thigh bone fracture.

Ivenix LVP infusion pump precisely controls the flow of fluids to a patient. A defect in pump administration sets may cause uncontrolled flow.