FDA recall Z-2953-2026

Product

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

Reason for recall

Devices could potentially be occluded or partially occluded.

Distribution

US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.

Key facts

Status

Ongoing

Initiation date

2026-06-15

Report date

2026-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Syracuse, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2953-2026