FDA Medical devices recall ·
One-piece Guedel airway, size 3, ISO 9.0, yellow recall
- Recall number
- Z-2276-2025
- Date
- (initiated June 20, 2025)
- Company / brand
- Intersurgical Inc
5010 Campuswood Dr Ste 102, East Syracuse, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8,640 pieces
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Why was it recalled?
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657
Distribution
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
States: Arizona California Connecticut Florida Hawaii Massachusetts Michigan Ohio Utah Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2276-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.