FDAFDA recall Z-2953-2026 · Aug 26, 2026
Intersurgical Inc: One-Piece Guedel Airway recall
Recall found
Product
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Reason for recall
Devices could potentially be occluded or partially occluded.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
- Quantity
- 1,575 units
- Distribution
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
- Recalling firm
- Intersurgical Inc, East Syracuse, NY
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-15
Source: openFDA enforcement record Z-2953-2026 · search recall number Z-2953-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.