Intersurgical Inc: Medical Device Recall in 2025 - (Recall #: Z-2276-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.

Product Classification:

Class II

Date Initiated: June 20, 2025

Date Posted: August 13, 2025

Recall Number: Z-2276-2025

Event ID: 97127

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.

Status: Ongoing

Product Quantity: 8,640 pieces

Code Information:

Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657

Distribution Pattern:

US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.

Voluntary or Mandated:

Voluntary: Firm initiated