# FDA recall Z-1055-2022

> **Karl Storz Endoscopy** · Class II · device recall initiated 2022-04-01.

## Product

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

## Reason for recall

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

## Distribution

U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.

## Key facts

- **Recall number:** Z-1055-2022
- **Recalling firm:** Karl Storz Endoscopy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-01
- **Report date:** 2022-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** El Segundo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1055-2022

## Citation

> AI Analytics. FDA recall Z-1055-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1055-2022. Source: US FDA. Licensed CC0.

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