[Washington, D.C. — March 26, 2026] — Medline Renewal, an AMDR member, completed a voluntary recall for several of its reprocessed electrophysiology catheters and an electrosurgical product. Medline Renewal informed customers promptly to pull these products off the shelves in July 2025 with updated lots recalled in December 2025. Through this process, the recalled devices were removed from hospital shelves, quarantined, documented and destroyed and the quantity reported back to Medline Renewal months ago. Medline Renewal complied with all FDA protocols as part of this recall. FDA reports no injuries or deaths have been reported.
On March 5th, FDA issued a recall alert about these same Medline Renewal devices. The delay in FDA’s reporting may appear as though additional devices were recalled. They were not. The alert reflects no new information.
The recall is limited to select devices reprocessed by Medline ReNewal. We refer you to Medline Renewal for any further questions on the recall.
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.
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.
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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* Update reorganizes the content without substantial changes.
Contact:
David Sheon
VP External Affairs
202 422-6999 / dsheon@amdr.org