Two Massachusetts companies have recently received warning letters from the U.S. Food and Drug Administration over their medical devices.

One warning letter was sent to Burlington-based LeMaitre Vascular Inc. following an inspection of its North Brunswick, New Jersey, site from March 4, 2025, through April 16, 2025. The federal agency cited quality system regulation violations in the manufacturing of its Artegraft Collagen Vascular Grafts.

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