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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Intersurgical Guedel Airway Devices Recalled for Plastic Burr Inhalation Risk

Agency Publication Date: August 6, 2025
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Summary

Approximately 11,440 Intersurgical Inc. Guedel airway devices are being recalled because they may contain small plastic burrs that can detach during use. If these burrs are inhaled, they could cause airway obstruction, tissue irritation, or infection. The recall affects Size 2 (green) and Size 3 (yellow) models distributed through medical channels. No injuries have been reported to date, and the manufacturer is voluntarily initiating the recall to ensure patient safety.

Risk

Small plastic burrs on the airway device may detach and be inhaled by the patient during use. This poses a risk of physical airway obstruction, internal tissue irritation, inflammation, and potential infection.

What You Should Do

  1. This recall affects Intersurgical Guedel airway devices in Size 2 (green, Model 1112080) and Size 3 (yellow, Model 1113090).
  2. Identify affected units by checking the lot numbers on the device packaging: Size 2 devices with Lot 32414447 and Size 3 devices with Lot 32420657.
  3. Stop using the recalled devices immediately.
  4. Contact Intersurgical Inc. or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: One-piece Guedel airway, size 2, ISO 8.0
Variants: Green
Model / REF:
1112080
Lot Numbers:
32414447
UDI:
05030267040698
5030267050659

Recall #: Z-2275-2025; Quantity: 2,800 pieces

Product: One-piece Guedel airway, size 3, ISO 9.0
Variants: Yellow
Model / REF:
1113090
Lot Numbers:
32420657
UDI:
05030267153961
5030267050680

Recall #: Z-2276-2025; Quantity: 8,640 pieces

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97127
Status: Active
Manufacturer: Intersurgical Inc
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 2 products (2,800 pieces; 8,640 pieces)
Distributed To: Arizona, California, Connecticut, Florida, Hawaii, Massachusetts, Michigan, Ohio, Utah, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.