FDA recall, , Moderate risk
Intersurgical Guedel Oropharyngeal Airways
One-Piece Guedel Airway devices could potentially be occluded or partially occluded.
Summary by Recall Canary from the FDA notice
What happened
Intersurgical Inc of East Syracuse, New York, recalled One-Piece Guedel Airway devices because they could potentially be occluded or partially occluded. The recall began June 15, 2026, and was added to the FDA's Enforcement Report on August 14, 2026. The devices were distributed in Connecticut, Florida, Indiana, Michigan, Ohio and Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
- UDI-DI
- 5030267049844
- 05030267044528
- 32190425
- 32213076
- 32221283
- 32307261
- 32317627
- 32321305
- 32513841
- 32517565
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
- UDI-DI
- 5030267050185
- 05030267044450
- 32121232
- 32208193
- 32400267
- 32403734
- 32408819
- 32409672
- 32416545
- 32427064
- 32605471
- 32606405
- 32606850
- 32607154
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Connecticut, Florida, Indiana, Michigan, Ohio & Virginia.
- Company
- Intersurgical IncEast Syracuse, New York
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99284
- Recall numbers
- Z-2952-2026 to Z-2953-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
