Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
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 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
- Lot codes and dates
- REF1100050
- Single Unit UDI5030267050185
- Case UDI
05030267044450Lot No. 321212323220819332400267324037343240881932409672324165453242706432605471326064053260685032607154
- Amount recalled
- 21,269 units
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
Devices could potentially be occluded or partially occluded.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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