Serious health risk
⚠ This recall is currently active
Intersurgical Inc
Devices recall · Z-2953-2026
Reason for recall
Devices could potentially be occluded or partially occluded.
Product description
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Recalling firm
Intersurgical Inc
Product quantity
1,575 units
Lot / code info
REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
Distribution
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Recall initiated
2026-06-15
Status
Ongoing
Location
East Syracuse, NY, United States
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Data from official federal safety records. Updated periodically. Verify on FDA.gov