Home / Recalls / Intersurgical Inc / Z-2276-2025

Z-2276-2025 Class II Ongoing

Recalled by Intersurgical Inc — East Syracuse, NY

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

Other recalls by Intersurgical Inc

  • Z-2275-2025 Class II — One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. (June 20, 2025)
  • Z-2102-2025 Class I — i-view video laryngoscope. Model Number: 8008000. The i-view video laryngosc (June 17, 2025)
  • Z-0096-2023 Class II — Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50k (August 29, 2022)
  • Z-0753-2021 Class II — Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Cu (November 11, 2020)
  • Z-0785-2020 Class II — Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030 (August 7, 2019)
  • Z-0784-2020 Class II — Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000 (August 7, 2019)
  • Z-0787-2020 Class II — Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port (August 7, 2019)
  • Z-0786-2020 Class II — Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port (August 7, 2019)
  • Z-2302-2018 Class II — Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 800 (April 25, 2018)
  • Z-0208-2018 Class II — Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: (April 3, 2017)