# FDA recall Z-0176-2022

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2021-09-21.

## Product

ASC PneumoLiner device, Part No. WA90500US (US market only)    The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multi- site laparoscopic surgery during power morcellation and removal.

## Reason for recall

Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and bag closure more difficult, introducing the risk of trapping the small bowel/viscera in the bag at closure resulting in patient injury.

## Distribution

US Nationwide distribution to states of:  AL, CA, CT, FL, IL, MD, MI, MN, MO, NE, NY, OH, OK, OR, PA, SC, UT, VA, WA, WI,  and WV ; and International (foreign) distribution to: Europe.

## Key facts

- **Recall number:** Z-0176-2022
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-21
- **Report date:** 2021-11-03
- **Termination date:** 2023-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0176-2022

## Citation

> AI Analytics. FDA recall Z-0176-2022. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-0176-2022. Source: US FDA. Licensed CC0.

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