Class II — LeMaitre Vascular, Inc.
| Recalling firm | LEMAITRE VASCULAR, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field. |
| Product | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00. |
| Quantity | 616 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain. |
| Initiated | 2021-04-06 |
| Classified | 2021-05-04 |
| Terminated | 2022-12-29 |
| Recall number | Z-1529-2021 |
| 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-1529-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87689/
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