One-piece Guedel airway, size 2, ISO 8.0, green. Model… recallZ-2275-2025 · Intersurgical Inc · initiated Jun 20, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intersurgical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2275-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 20, 2025
- Posted by the FDA
- Aug 6, 2025
- Recalling firm
- Intersurgical Inc
- Quantity
- 2,800 pieces
- Product code
- CAE
- Distribution
- US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Product description
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Code information (models, lots, serial numbers)
Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GUEDEL AIRWAY, SIZE 2, ISO 8 1112080Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97127).
- Z-2276-2025 · Open, ClassifiedOne-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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