One-piece Guedel airway recall: Contamination
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Why was One-piece Guedel airway recalled?
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447
- Product
- One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
- Recalling firm
- Intersurgical Inc
- Quantity
- 2,800 pieces
- Distribution
- US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
- Recall date
- August 13, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)