Z-2276-2025 Class II Ongoing
FDA device recall Z-2276-2025 was initiated by Intersurgical Inc on June 20, 2025 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 8,640 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2025
- Initiation Date
- June 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,640 pieces
Product Description
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Reason for Recall
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.
Distribution Pattern
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Code Information
Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657