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Lower risk Medical device recall · FDA · Published June 20, 2025

Intersurgical One-piece Guedel Airway Recall: Small Burrs Risk Airway Obstruction

Intersurgical recalls green size 2 Guedel airways with model 1112080 due to potential small burrs that could cause airway blockage, irritation, or infection if inhaled.

🇺🇸 FDA recall #Z-2275-2025Medical deviceIntersurgical ›
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Recalling firmIntersurgical Inc5010 Campuswood Dr Ste 102 · East Syracuse, NY 13057-1561
✎ GovInfoNow plain-language explainer

Intersurgical is recalling green size 2 Guedel airways with model number 1112080 because small burrs inside could detach and be inhaled, leading to airway blockage or infection. This affects medical devices used during procedures like intubation. Read more at govinfonow.com/recall/52001-intersurgical-one-piece-guedel-airway-recall-small-burrs-risk-airway.

Source Summary by GovInfoNow · govinfonow.com/recall/52001-intersurgical-one-piece-guedel-airway-recall-small-burrs-risk-airway · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2275-2025

Cite this page

“Intersurgical One-piece Guedel Airway Recall: Small Burrs Risk Airway Obstruction.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52001-intersurgical-one-piece-guedel-airway-recall-small-burrs-risk-airway. Based on FDA recall #Z-2275-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2275-2025%22&limit=1).

The FDA announced on June 20, 2025, that Intersurgical Inc is recalling One-piece Guedel airways due to potential contamination with small burrs. Owners should stop using the product immediately and contact the company for a refund.

How to tell if you have it

  • Brand: Intersurgical
  • Product: One-piece Guedel airway, size 2, ISO 8.0, green
  • Model Number: 1112080
  • Lot Number: 32414447
  • Quantity: 2,800 pieces

The hazard

The airways may contain small burrs that could detach and be inhaled, potentially causing airway obstruction, tissue irritation, inflammation, and infection. The FDA classifies this as a Class II recall.

Context

GovInfoNow's records show Intersurgical Inc has issued six other recalls since April 25, 2018. Recent similar product recalls include the Medcraft Forward OPA Kits (July 7, 2026), Medline Airway Exam Kit (Feb. 16, 2026), and Medline Intubation Tray (Dec. 24, 2025).

How to tell if you have this one

Look for green color, size 2, ISO 8.0, model number 1112080, or lot number 32414447 on the device. The UDI-DI (Case) is 05030267040698 and UDI-DI (Single Unit) is 5030267050659.

  • Brand
    Intersurgical
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Recall numberProduct, codes & lotsQuantity
Z-2275-2025One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.; Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 324144472,800 pieces
Z-2276-2025One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.; Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 324206578,640 pieces
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Identify the model number, color, size, and lot number to confirm if your device is recalled.

Where it went and when

Where it was distributed

Distributed in 10 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: yesHITexas: not listedTXFlorida: yesFL

FDA distribution: “US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Connecticut, Florida, Hawaii, Massachusetts, Michigan, Ohio, Utah, Virginia.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Jun 20, 202512. FDA classified it Class II: Aug 6, 202523. Published in FDA’s Enforcement Report: Aug 13, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The recall indicates potential contamination with small burrs that could cause airway issues if inhaled, so it is not safe to use without checking the recall.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2275-2025 (June 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2275-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA