Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks.
Here are some of the latest recalls reported to the FDA:
Airlife and Vyaire medical recalled certain Infant Heated Wire Circuits used in neonatal and infant ventilation due to the risk of adapter discontinuation during use. If the accessory adapter detaches once the system reaches operating temperature, it could lead to hypoxia, hypercapnia, organ failure or death. Healthcare providers are advised to stop using any affected circuits with adapter connections and conduct frequent monitoring of ventilator settings and alarms. No injuries or deaths have been reported.
Airlife issued a recall for its 2025 edition of the Broselow pediatric emergency rainbow tape due to incorrect printed information in the red, orange and gray zones. Errors include inaccurate joule dosing for fibrillation and incorrect sodium bicarbonate concentrations which could lead to severe outcomes including cardiac arrest, metabolic imbalances or worsened respiratory status. No injuries or deaths have been reported.
Baxter is alerting providers of a software error affecting certain Sigma Spectrum V6 and V8 infusion pumps. Some units may have been programmed with the incorrect version of software, leading to inaccurate flow rates. The issue could cause underinfusion or overinfusion, posing a risk of drug toxicity, overload or treatment delays. No injuries or deaths have been reported.
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