One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Devices could potentially be occluded or partially occluded.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
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5 reported ongoing
6 records in this archive. Latest source date Jun 15, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Devices could potentially be occluded or partially occluded.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Devices could potentially be occluded or partially occluded.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
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.
Class IIReported ongoing
Distribution: US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
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.
Class IIReported ongoing
Distribution: US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Potential for faulty devices as a result of depleted batteries.
Class IReported ongoing
Distribution: US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.
Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on t...
Class IIReported terminated
Distribution: OH, TN, TX
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 6 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.