FDA Medical devices recall ·
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green recall
- Recall number
- Z-2953-2026
- Date
- (initiated June 15, 2026)
- Company / brand
- Intersurgical Inc
5010 Campuswood Dr Ste 102, East Syracuse, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,575 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Why was it recalled?
Devices could potentially be occluded or partially occluded.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Connecticut Florida Indiana Michigan Ohio Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2953-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.