One-Piece Guedel Airway recall (Intersurgical Inc)
Medical deviceClass IIOngoing
Summary: Intersurgical Inc is recalling One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.. Reason: Devices could potentially be occluded or partially occluded.
What is being recalled
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Why
Devices could potentially be occluded or partially occluded.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA. (states named: Connecticut, Florida, Indiana, Michigan, Ohio, Virginia)
How to tell if yours is affected
REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2953-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 15, 2026 |
| Reported | August 26, 2026 |
| Company | Intersurgical Inc |
| Company location | East Syracuse, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1,575 units |
More recalls from Intersurgical Inc · all medical device recalls · recalls from June 2026