Intersurgical Inc recalls One-Piece Guedel Airway
- Recalling company
- Intersurgical Inc
- Product
- One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
- Reason
- Devices could potentially be occluded or partially occluded.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 15, 2026
- Reported
- Aug 26, 2026
- Distribution
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
- Status
- Ongoing
- Quantity
- 1,575 units
- Lot / codes
- REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
- Company location
- East Syracuse, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2953-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2953-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.