Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19585 |
| Brand Name: | Ambu Laryngeal Mask, single-use |
| Model: | AMB408-300-000 |
| Affected: | 1794260, 1745425, 1724948, 1794260, 1729556, 1724950, 1732622 |
| Software version: | |
| Recalling Organisation: | Medxus Ltd Unit 4 100 Fitgerald Avenue Christchurch 8011 |
| Contact Information: | 03 365 7403 |
| Manufacturer: | Ambu AS |
| Issue: | Potential sterility breach. A failure has been discovered during routine quality control at the manufacturing site. This failure may cause a small hole, (approximately 0.5mm) in the pouch of the device leading to a potential compromised sterile barrier. After identification of failure, comprehensive investigation has shown a low prevalence of up to 3% for the affected LOTs. Manufacturer has not received any complaints or other market feedback on the matter, dating from when the products were marketed in 2014. . |
| Recall action type: | Recall |
| Recall action: | |
| Level of recall: | |
| Date Commenced: | 18/12/2015 |
