The FDA announced on June 15, 2026, that Intersurgical Inc is recalling One-Piece Guedel Airway devices due to potential occlusion hazards. Owners should contact the company for a remedy.
How to tell if you have it
- Brand: Intersurgical
- Product: One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device
- REF: 1100050
- Single Unit UDI: 5030267050185
- Case UDI: 05030267044450
- Lot codes: 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154
- Quantity: 21,269 units
- Distribution: US Nationwide in CT, FL, IN, MI, OH & VA
The hazard
According to the FDA, the devices could potentially be occluded or partially occluded.
Context
GovInfoNow's records show Intersurgical Inc has 6 other recalls on record since 2018-04-25. Other recent recalls of similar products include Medcraft Forward OPA Kits (2026-07-07) and Medline Airway Exam Kit Recall (2026-02-16).