Recall archive / FDA device enforcement
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. — FDA record Z-2276-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 20, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Intersurgical Inc
- Quantity
- 8,640 pieces
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2276-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 13, 2025
- Recall initiation date
- Jun 20, 2025
- Center classification date
- Aug 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.