Class II — W L Gore & Associates, Inc.
| Recalling firm | W. L. GORE & ASSOCIATES, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The incorrect label was placed on both the primary and secondary package. |
| Product | Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta. |
| Quantity | 15 stents |
| Distribution | International the country of Japan. |
| Initiated | 2019-12-17 |
| Classified | 2020-05-20 |
| Terminated | 2021-04-28 |
| Recall number | Z-2052-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — W L Gore & Associates, Inc. (Z-2052-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85434/
Alerts for W. L. GORE & ASSOCIATES, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.