FDA Issues Urgent Recall for Millions of Vyaire Medical Hand-Powered Resuscitators

The Food and Drug Administration (FDA) has issued a public advisory regarding an ongoing recall of millions of hand-powered bag valve masks, commonly used in emergency medical situations. These disposable devices, crucial for providing respiratory support to patients experiencing breathing difficulties or respiratory arrest, are manufactured by Vyaire Medical under the AirLife brand.

The recall encompasses various sizes and accessories of Vyaire Medical’s AirLife adult manual resuscitators, totaling approximately 6.6 million units. According to the FDA, devices manufactured in 2017 or earlier may contain a manufacturing defect that could compromise their ability to deliver sufficient ventilation to patients, potentially resulting in serious consequences.

In its latest notice, the FDA disclosed that it has documented 37 incidents associated with the recalled resuscitators, including two cases of injury and two fatalities. The defect, attributed to a broken duckbill valve and ring caused by faulty components, prompted the FDA to classify the issue as a Class I recall, indicating the highest level of concern.

Vyaire Medical promptly alerted its customers to the recall through an urgent notification on January 10, emphasizing the risk of hypoventilation posed by the defective devices. Despite corrective measures implemented in 2017, older models may still be in circulation globally, necessitating thorough inspection and, if necessary, disposal as per FDA guidelines. Notably, the FDA emphasized that the recalled equipment should not be returned to either Vyaire Medical or its previous owner, SunMed.

Vyaire Medical, originally established in 2016 as a joint venture between BD’s respiratory division and Apax Partners, underwent changes in ownership, with Apax Partners assuming full control in 2018. The company’s decision to divest its respiratory and anesthesia consumables business to SunMed in 2023 preceded the recall, further complicating the supply chain dynamics.

Highlighting the severity of the situation, the FDA reiterated that the continued use of the recalled devices could lead to major injuries or fatalities, underscoring the critical importance of prompt action. While the manufacturing defect was addressed in 2017, the FDA cautioned that devices distributed before the correction may still be in circulation, warranting immediate attention.

Vyaire Medical initiated the recall process on December 6 of the preceding year, targeting over 6.6 million devices distributed across the United States. The recalled devices either lacked a manufacturing date or were produced before 2017, indicating a broad scope of potential impact on healthcare facilities and emergency responders.

Despite repeated attempts, Vyaire Medical has not provided a comment in response to inquiries regarding the recall. This lack of communication raises concerns about transparency and accountability in addressing critical issues affecting patient safety.

As the recall unfolds, healthcare providers and emergency responders are urged to exercise vigilance, promptly identifying and removing affected devices from circulation to mitigate the risk of harm to patients. The FDA remains committed to monitoring the situation closely and facilitating appropriate actions to safeguard public health.