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Intersurgical Inc: One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

Medical DevicesSource: FDA (device) · Date: 2026-08-26

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Intersurgical Inc
Product
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Reason / hazard
Devices could potentially be occluded or partially occluded.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Recall initiated
2026-06-15
Code info
REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
Product quantity
1,575 units
Voluntary mandated
Voluntary: Firm initiated
City
East Syracuse
State
NY
Country
United States
Event id
99284
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