Class II — Intersurgical Inc
| Recalling firm | INTERSURGICAL, INC. |
|---|---|
| Registered facility | INTERSURGICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. |
| Quantity | 2,800 pieces |
| Distribution | US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA. |
| Initiated | 2025-06-20 |
| Classified | 2025-08-06 |
| Recall number | Z-2275-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Intersurgical Inc (Z-2275-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97127/
Alerts for INTERSURGICAL, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.