The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury.

Related Recalls - Plastic Syringes Made In China for Potential Device Failures

Vivo 45 LS ventilators support breathing in homes and health settings. New devices may expose users to elevated formaldehyde levels for a short time.

FreeStyle Libre 3 sensor provides continuous monitoring of glucose levels but a small number of sensors may give inaccurate high readings

McGrath MAC Video Laryngoscopes help visualize the trachea and larynx. The batteries on these devices may deplete too much, causing overheating and explosion.

Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona® Tracheostomy Tubes

The Volara System provides lung therapy for patients on ventilators but some single-patient use circuits and blue ventilator adapter assemblies may disconnect.

Tandem Diabetes Care, Inc. recalls t:connect mobile app (v2.7) for t:slim X2 insulin pump due to software issue that may cause app to crash and deplete pump battery

Listing of Medical Device 2023 Safety Communications

A voluntary recall initiated by SoClean for use of SoClean2 and SoClean3 equipment to clean, sanitize or disinfect CPAP devices and accessories.

ClotTriever XL is used to remove clots and blockages in large vessels. Inari is updating Use Instructions after reports of entrapment and pulmonary emboli.

Syringes included in Medline Convenience Kits should not be used due to risk for contamination, breakage, or leakage.

The RMU-2000 ARM XR Chest Compression Device provides external chest compressions. A motor issue may cause the device to unexpectedly stop.

If a Plum 360, A+ or A+3 pump is running on battery power with no AC backup, an ongoing infusion may be stopped when batteries unexpectedly run out.

Listing of Medical Device 2024 Safety Communications

2024 Medical Device Recalls

Tandem Diabetes Care, Inc. (Nasdaq: TNDM) today provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States relating to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. This battery depletion can result in the pump shuttin

Abiomed Impella CP with SmartAssist provides short-term support to the heart’s ventricle. Nine pumps that failed inspections were mistakenly sent to customers.

On August 5, 2024, Breas Medical initiated a U.S. nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions. Short term formaldehyde emissions m

B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the resp