# FDA recall Z-0178-2022

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2021-08-09.

## Product

Bivona Uncuffed Wire Endotracheal Tubes,

## Reason for recall

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, KY, MA, MN, MO, NE, NJ, NY, OH, PA, SD, TN, TX, VA, WA and Hawaii. The countries of Bermuda, Canada, Germany, Denmark, Great Britain and Italy.

## Key facts

- **Recall number:** Z-0178-2022
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-09
- **Report date:** 2021-11-03
- **Termination date:** 2023-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0178-2022

## Citation

> AI Analytics. FDA recall Z-0178-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0178-2022. Source: US FDA. Licensed CC0.

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