Ambu Inc is recalling Spur II manual resuscitators due to the manometer port being blocked, which renders the manometer non-functional, according to an FDA alert.
The Ambu Spur II resuscitator is a single patient use resuscitator intended for pulmonary resuscitation and emergency respiratory support.
According to the FDA, 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 FDA warns that use of affected product may cause serious adverse health consequences, including barotrauma, collapsed lung (pneumothorax), and death, however no reported injuries and no reports of death have been associated with this issue.
FDA Recommendations
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.
For more information, including a full list of affected devices, visit the FDA website.
