[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 members are expected to meet FDA’s standards of quality, safety, and regulatory compliance, and comply with AMDR’s code of conduct as a condition of membership.

Medline Renewal, an AMDR member, completed a voluntary recall for several of its reprocessed electrophysiology catheters and an electrosurgical product. We understand Medline Renewal has complied with all FDA protocols as part of this recall.  FDA reports no injuries or deaths have been reported. We refer you to Medline Renewal for any further questions on the recall. All other AMDR members report they are in compliance with FDA requirements.

On March 5th, FDA issued a recall alert about Medline Renewal products that were voluntarily recalled and posted to FDA’s recall website months earlier (as far back as July 2025).  FDA is considerably delayed in its reporting.  The alert reflects no new information and all customers were told weeks or months ago to quarantined, document and destroy all recalled product and report back to Medline the quantity of affected product in inventory.

Independent studies and decades of hospital experience show that FDA-regulated reprocessed devices are as safe and effective as original equipment, while also reducing healthcare costs and medical waste. AMDR and its members will continue to uphold these standards, including working in full cooperation with regulators, to maintain safety and public trust.

About AMDR

The Association of Medical Device Reprocessors (AMDR) is the global trade association for the regulated, commercial “single-use” device reprocessing and remanufacturing industry. AMDR members serve over 9,400 hospitals and surgical centers in the U.S., Canada, Europe, Japan and Australia.

Founded in 1997, AMDR advocates for reprocessing and remanufacturing as an important healthcare strategy that helps hospitals and healthcare providers to strengthen the supply chain while simultaneously reducing costs, waste, and emissions. AMDR protects the interests of its members in regulation, legislation, and standard-setting.

AMDR protects the interests of its members in regulation, legislation, and standard-setting. AMDR members include Arjo ReNu Medical, Innovative Health, Medline ReNewal, Stryker’s Sustainability Solutions, Sustainable Technologies (a Cardinal Health Business), Vanguard AG, and Vein360. Having played a key role in the establishment of the reprocessing industry, AMDR continues to push the global medical technology industry, leading the way for remanufacturing to play a defining role in the evolution of new device technologies.

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Contact:

David Sheon
VP External Affairs
202 422-6999 / dsheon@amdr.org