FDA Recalls Ambu SPUR II Manual Resuscitators Over Blocked Manometer Port Defect

Critical backup ventilation devices face Class I recall due to risk of inaccurate airway pressure monitoring

The U.S. Food and Drug Administration (FDA) has issued a Class I recall, its most serious designation, for specific batches of Ambu SPUR II manual resuscitators. The recall stems from a defect in the devices’ manometer ports, which may be blocked and prevent clinicians from accurately monitoring airway pressure during manual ventilation.

Manual resuscitators are essential tools used in operating rooms, emergency departments, and ambulances when patients require immediate respiratory support. The FDA warns that the defect could cause serious complications, including hypoxia, barotrauma, or death if not promptly addressed.

Ambu A/S, a Denmark-based manufacturer with a large presence in U.S. hospitals, identified that certain SPUR II manual resuscitators had blocked manometer ports. These ports are designed to connect to a pressure gauge, giving clinicians a real-time reading of ventilation pressures delivered to a patient.

If the port is blocked, clinicians cannot verify airway pressures during bag-valve-mask ventilation. This introduces two main risks:

Underventilation: Inadequate ventilation leading to oxygen deprivation.

Overventilation: Excessive pressure delivery, causing barotrauma, aspiration, or gastric insufflation.

Because SPUR II devices are widely distributed and considered standard-of-care backup equipment, the defect carries broad implications for hospitals, surgery centers, and emergency medical services.

Manual resuscitators may appear simple compared to advanced ventilators, but they are vital safety devices. In surgical and critical care environments, they are relied upon as a fail-safe option if automated systems malfunction.

In the operating room: Used if anesthesia ventilators fail or during rapid resuscitation events.

In emergency departments and ICUs: Deployed in cardiac arrest or respiratory failure scenarios.

In ambulances and transport settings: Often the first device used in prehospital emergencies.

The recall therefore affects a wide spectrum of clinical environments, from elective surgeries to trauma care. A single defective resuscitator could compromise patient outcomes in time-critical emergencies.

Anesthesiologists and Nurse Anesthetists: Depend on manual resuscitators as a backup during procedures.

Respiratory Therapists and Emergency Physicians: Use these devices routinely in codes and rapid responses.

EMS Providers: Carry SPUR II devices in ambulances for prehospital ventilation.

Biomedical Engineering and Supply Chain Teams: Must conduct audits, quarantine affected stock, and arrange replacements.

Hospital Safety Committees: Responsible for reporting and mitigating risks associated with the recall.

Dr. James Holloway, Chief of Anesthesiology at a regional trauma center, stated:

“We treat manual resuscitators as our last line of defense. A blocked manometer port undermines our ability to ventilate safely in an emergency. Even though the device is basic, the risk is anything but minor.”

Maria Lopez, a medical device safety consultant, added:

“This recall is a reminder that even low-cost, single-use devices can cause systemic risks. Hospitals cannot take reliability for granted, even in consumables.”

Recommended Actions

• The FDA and Ambu have issued the following guidance:

• Audit inventories immediately for affected SPUR II devices.

• Remove and quarantine recalled devices to prevent clinical use.

• Notify frontline staff in surgical, emergency, and EMS units.

• Contact Ambu for return and replacement instructions.

• Report any device-related adverse events via the FDA’s MedWatch portal.

Strategic Implications for Health Systems

Supply Disruption: Hospitals that rely heavily on SPUR II devices may need to source alternatives rapidly.

Infection Control Considerations: Many hospitals adopted disposable resuscitators to reduce contamination risks; shifting back to reusable models could reintroduce sterilization burdens.

Training Needs: EMS and hospital staff accustomed to SPUR II ergonomics may need refresher training if alternative products are substituted.

The recall of Ambu SPUR II manual resuscitators demonstrates that even the simplest surgical and emergency devices require vigilance and quality oversight. As hospitals respond to the FDA’s Class I designation, procurement leaders, clinicians, and biomedical teams must coordinate quickly to safeguard patients and ensure uninterrupted readiness in critical scenarios.