Device recall

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

FDA recall source

Recall number

Z-2953-2026

Event id

99284

Status

Ongoing

FDA classification

Class II

Recalling firm

Intersurgical Inc

Report date

Aug 26, 2026

Initiated

Jun 15, 2026

Center classification date

Aug 14, 2026

Reason

Devices could potentially be occluded or partially occluded.

Quantity

1,575 units

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.

Voluntary or mandated

Voluntary: Firm initiated

Location

East Syracuse, NY, United States