medical MODERATE Updated 2025-08-13

Intersurgical Inc recalls One-piece Guedel airway, size 2, ISO 8.0, green. Model Numbe

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Recalled Product

One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

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Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, CT, FL, HI, MA, MI, OH, UT, VA
Lot/Code Info: Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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