Ambu® SPUR®II Adult and Pediatric Resuscitator
Brand(s)
Summary
Discard the affected products and contact the manufacturer for a refund or replacement.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Ambu® SPUR®II Adult Resuscitator | 1001113554 | 523211000 |
| Ambu® SPUR®II Adult Resuscitator | 1001118764 | 523211000 |
| Ambu® SPUR®II Adult Resuscitator | 1001110297 | 524611000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001110299 | 530213000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001106636 | 530214000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001113558 | 530213000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001106635 | 530213001 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001106637 | 530613000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001118767 | 530213000 |
| Ambu® SPUR®II Pediatric Resuscitator | 2000015889 | 530613031 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001113560 | 530213031 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001106634 | 530213000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001118769 | 530213031 |
Issue
A total of five complaints have been reported for the SPUR II device regarding a blocked manometer port, rendering the attached manometer non-functional. No patient involvement has been reported. In the affected devices, pressure monitoring is not possible via the manometer port or the attached manometer. While the SPUR II's ability to deliver oxygen remains intact, this defect increases the risk of barotrauma if the pressure-limiting valve is overridden. It may also lead to procedural delays and temporary hypoxia due to user uncertainty when operating a device without a functional manometer.
Recall start date: July 14, 2025
Additional information
Details
Ambu A/S
Baltorpbakken 13, Ballerup, Denmark, 2750
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