Z-2276-2025Class II

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

Name: Z-2276-2025 One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090
Creator: Intersurgical Inc
Published: 2025-06-20
License: https://open.fda.gov/license/

Intersurgical Ltd. / initiated 2025-06-20 / Open, Classified / root cause: manufacturing process

FDA source

Intersurgical Inc began a recall of One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090 on 2025-06-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2276-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-20
Posted: 2025-08-06
Recalling firm: Intersurgical Ltd.
Product: One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Product code: CAE Airway, Oropharyngeal, Anesthesiology
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Intersurgical notified consignees on 06/20/2025 via email with recall letter. Consignees were instructed to immediately discontinue use and quarantine any affected units, immediately notify customers if product has been further distributed, arrange for the return of affected units and complete the Customer Product Recall Acknowledgement Form.
Quantity in commerce: 8,640 pieces
Distribution: US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Product codes and lots: Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2276-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2275-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-06
Z-2276-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-06

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)