Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.  

Affected Product

• Product Name: Ambu SPUR II Resuscitator
• Full list of affected devices

What to Do

Do not use Ambu SPUR II resuscitators from affected lots. Identify and discard resuscitators from affected lots. 

On July 8, 2025, Ambu sent all affected customers an Urgent Field Safety Notice recommending the following actions:

• Identify if any Ambu SPUR II products at the facility are from affected lots.
• Complete and return Appendix 1 of the Field Safety Notice to:
  • Confirm receipt and provide the number of affected items in your possession.
  • Confirm affected items have been discarded.
  • Note if refund or replacement is needed for discarded items.
• Pass the notice on to everyone who needs to be aware in the organization and to any organization where devices have been transferred. 
• Maintain awareness of the notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.

Reason for Recall

Ambu Inc. is recalling the SPUR II resuscitator due to the manometer port being blocked, which renders the manometer non-functional. This defect can lead to an increased risk of harm caused by pressure changes (barotrauma) and delayed ventilation, since the ventilation pressure applied with Ambu SPUR II cannot be read on the manometer. 

The use of affected product may cause serious adverse health consequences, including barotrauma, collapsed lung (pneumothorax), and death.  

There have been no reported injuries and no reports of death associated with this issue.

Device Use

The Ambu SPUR II resuscitator is a single patient use resuscitator intended for pulmonary resuscitation and emergency respiratory support.

Contact Information

Customers in the U.S. with questions about this recall should contact their local sales representative.

Additional FDA Resources (listed in order of most to least recent):

• FDA’s Enforcement Report 
• Medical Device Recall Database

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?  
• AccessGUDID database - Identify Your Medical Device  
• Benefits of a UDI System   

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Read the full alert.