AMDR Statement on Voluntary Recalls of Medline Renewal Reprocessed Devices
[Washington, D.C. — March 8, 2025] — Patient safety is the medical device reprocessing industry’s highest priority. Regulated by the U.S. Food and Drug Administration (FDA), single use device reprocessors are subject to stringent regulation and are required to show that a reprocessed device will remain substantially equivalent to the original device, post-reprocessing. All AMDR

