One-Piece Guedel Airway recall
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Why was One-Piece Guedel Airway recalled?
Devices could potentially be occluded or partially occluded.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
- Product
- One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
- Recalling firm
- Intersurgical Inc
- Quantity
- 1,575 units
- Distribution
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
- Recall date
- August 26, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)