FDAHealthJune 20, 2025
Intersurgical Inc — One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
⚠️ 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.
Is this relevant to me?
- Geography
- US, AZ, CA, CT, FL, HI, MA, MI, OH, UT, VA
- Source agency
- FDA
- Category
- Health
- Published
- June 20, 2025
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
What's affected?
- Product
- One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
- Brand
- Intersurgical Inc
- Lot code
- 32414447
Additional details
Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2,800 pieces.
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