ASC PneumoLiner device — Class II medical device recall Z-0176-2022
Terminated recall by Olympus Corporation of the Americas, reported 2021-11-03, distributed nationwide. Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong ori
| Recall number | Z-0176-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2021-09-21 |
| Classified | 2021-10-26 |
| Reported by FDA | 2021-11-03 |
| Terminated | 2023-09-08 |
| Distributed | Nationwide (US) |
| Lot numbers | 647572, 667060 |
| Model numbers | WA90500US |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0176-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.