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Use caution Medical device recall · FDA · Published June 15, 2026

Intersurgical One-Piece Guedel Airway Blue: Potential Occlusion Risk

Intersurgical recalls blue size 00 Guedel airway devices (ISO 5.0) due to potential occlusion. Affected units include specific lot numbers and serial codes. Consumers should contact for details.

🇺🇸 FDA recall #Z-2952-2026Medical deviceIntersurgical ›
✎ GovInfoNow plain-language explainer

Intersurgical is recalling blue size 00 Guedel oropharyngeal airway devices that could become partially blocked. This risk could prevent proper airway management during medical procedures. Read more at govinfonow.com/recall/698043-intersurgical-one-piece-guedel-airway-blue-potential-occlusion-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/698043-intersurgical-one-piece-guedel-airway-blue-potential-occlusion-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-2952-2026

Cite this page

“Intersurgical One-Piece Guedel Airway Blue: Potential Occlusion Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/698043-intersurgical-one-piece-guedel-airway-blue-potential-occlusion-risk. Based on FDA recall #Z-2952-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2952-2026%22&limit=1).

The FDA announced on June 15, 2026, that Intersurgical Inc is recalling One-Piece Guedel Airway devices due to potential occlusion hazards. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Intersurgical
  • Product: One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device
  • REF: 1100050
  • Single Unit UDI: 5030267050185
  • Case UDI: 05030267044450
  • Lot codes: 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154
  • Quantity: 21,269 units
  • Distribution: US Nationwide in CT, FL, IN, MI, OH & VA

The hazard

According to the FDA, the devices could potentially be occluded or partially occluded.

Context

GovInfoNow's records show Intersurgical Inc has 6 other recalls on record since 2018-04-25. Other recent recalls of similar products include Medcraft Forward OPA Kits (2026-07-07) and Medline Airway Exam Kit Recall (2026-02-16).

How to tell if you have this one

Check for blue color, size 00, ISO 5.0, and the specific lot numbers listed: 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.

  • 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 Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Recall numberProduct, codes & lotsQuantity
Z-2952-2026One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.; REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.21,269 units
Z-2953-2026One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.; REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.1,575 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Verify the blue color, size 00, ISO 5.0, and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Connecticut, Florida, Indiana, Michigan, Ohio, Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jun 15, 202612. FDA classified it Class II: Aug 14, 202623. Published in FDA’s Enforcement Report: Aug 26, 202634. Added to GovInfoNow: Sep 8, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

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

✎ GovInfoNow

Questions people ask

What should I do if I have this device?

Contact Intersurgical directly for specific instructions on how to handle the device.

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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-2952-2026 (June 15, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2952-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 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