Class II — LeMaitre Vascular, Inc.
| Recalling firm | LeMaitre Vascular, Inc. |
|---|---|
| Registered facility | LEMAITRE VASCULAR, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The device was incorrectly packed in the wrong size labeled outer packaging. |
| Product | Artegraft® Collagen Vascular Graft; REF: AG1015; |
| Quantity | 1 unit |
| Distribution | US distribution to the state of: AR |
| Initiated | 2025-09-25 |
| Classified | 2025-10-23 |
| Recall number | Z-0289-2026 |
| 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 — LeMaitre Vascular, Inc. (Z-0289-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97700/
Alerts for LeMaitre Vascular, 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.