# FDA recall Z-2275-2025

> **Intersurgical Inc** · Class II · device recall initiated 2025-06-20.

## Product

One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

## Reason for recall

Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

## Distribution

US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.

## Key facts

- **Recall number:** Z-2275-2025
- **Recalling firm:** Intersurgical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-20
- **Report date:** 2025-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Syracuse, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2275-2025

## Citation

> AI Analytics. FDA recall Z-2275-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2275-2025. Source: US FDA. Licensed CC0.

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