Reported Aug 13, 2025 · Ongoing
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Intersurgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intersurgical Inc · 5010 Campuswood Dr Ste 102 · East Syracuse, NY · 13057-1561
Is this the product you have?
- One-piece Guedel airway, size 2, ISO 8.0, green
- Model Number1112080
- Lot codes and dates
- Model Number1112080
- UDI-DI (Case)05030267040698
- UDI-DI (Single Unit)5030267050659
- Lot Number32414447
- Amount recalled
- 2,800 pieces
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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