FDA Device recall Z-2276-2025
One-piece Guedel airway, size 3, ISO 9.0, yellow
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of One-piece Guedel airway, size 3, ISO 9.0, yellow by Intersurgical, citing potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2276-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-20 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Intersurgical |
| Distribution | AZ, CA, CT, FL, HI, MA, MI, OH, UT, VA |
Product
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Reason
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.
Identifiers
| code_info | Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2276-2025%22
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