The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.
Ambu Inc is recalling its SPUR II single-patient use, manual resuscitators after discovering a defect that has prompted the US Food and Drug Administration (FDA) to classify the action as a Class I recall, the most serious type. The agency warns that use of the device may cause serious injury or death.
The recall stems from a blocked manometer port on the device, which renders the manometer non-functional. This defect prevents clinicians from reading the ventilation pressure being applied to a patient during pulmonary resuscitation. The inability to monitor pressure can lead to delayed ventilation or barotrauma, potentially causing a collapsed lung and death.
The Ambu SPUR II resuscitator is intended for pulmonary resuscitation and emergency respiratory support. According to the FDA notice, there have been no reported injuries or deaths associated with this issue.
On July 8, 2025, Ambu distributed an Urgent Field Safety Notice to all affected customers. The notice instructs healthcare facilities to immediately identify and discard all resuscitators from the affected lots. Customers in the US with questions regarding the recall are advised to contact their local sales representative.
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