# FDA recall Z-0208-2018

> **Intersurgical Inc** · Class II · device recall initiated 2017-04-03.

## Product

Solus Flexible wire-reinforced laryngeal mask airways under the following sizes:  1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001    Patent airway management.

## Reason for recall

A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.

## Distribution

Worldwide Distribution - US Distribution to the states of :  IL, KY, OH, NY & VA and to the countries of : Canada & Mexico

## Key facts

- **Recall number:** Z-0208-2018
- **Recalling firm:** Intersurgical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-04-03
- **Report date:** 2017-12-13
- **Termination date:** 2019-06-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0208-2018

## Citation

> AI Analytics. FDA recall Z-0208-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0208-2018. Source: US FDA. Licensed CC0.

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