Guedel Airway Intersurgical

Recalling firm
InterMed Medical Ltd
Product
Guedel Airway Intersurgical. [Device]. Model: Product code - 1100050 – One-piece Guedel airway, size 00, ISO 5.0, blue and Product code - 1000035 One-piece Guedel airway, size 000, ISO 3.5, light green. Affected: All lot numbers with an expiry date in the range 2026-06 to 2031-02, as indicated on the product label.
Reason
During manufacture, some Guedel Airway devices have been identified with occluded or partially occluded tips., The hazard arising from this manufacturing fault depends on the level of occlusion. Potential problems include, but are not, limited to, respiratory distress, laryngospasm, stridor, stenosis, oedema, neurological impairment, hypoxia,, hypoxemia and cyanosis and their consequences.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-06-11
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/eb94b101-bfab-4a7d-a1f9-6eb13a3d735d