FDAFDA · Food and drugs·Recall number Z-2952-2026
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Published August 26, 2026 · Recall initiated: June 15, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Devices could potentially be occluded or partially occluded.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Intersurgical Inc
- Distributor
- US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
- Lot
- REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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