# FDA recall Z-0096-2023

> **Intersurgical Inc** · Class II · device recall initiated 2022-08-29.

## Product

Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg    Model Number: 8003000

## Reason for recall

Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient

## Distribution

OH, TN, TX

## Key facts

- **Recall number:** Z-0096-2023
- **Recalling firm:** Intersurgical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-08-29
- **Report date:** 2022-10-26
- **Termination date:** 2023-10-19

- **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-0096-2023

## Citation

> AI Analytics. FDA recall Z-0096-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0096-2023. Source: US FDA. Licensed CC0.

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