Intersurgical Inc: Medical Device Recall in 2025 - (Recall #: Z-2275-2025)

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 2, ISO 8.0, green. Model Number: 1112080.

Product Classification:

Class II

Date Initiated: June 20, 2025

Date Posted: August 13, 2025

Recall Number: Z-2275-2025

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: 2,800 pieces

Code Information:

Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated