Update relating to Unomedical following United States Food and Drug Administration (FDA) Remote Regulatory Assessment

London, UK, 3 February 2026 – Unomedical Devices, S.A. de C.V., a Convatec subsidiary, has received a Warning Letter from the FDA following a remote regulatory assessment relating to its Infusion Care business. The letter focuses on reporting procedures and protocols relating to the quality management system. The letter does not raise concerns relating to product safety or place any restrictions on the production, marketing, manufacturing or distribution of any Unomedical products. 

As a leading manufacturer of infusion sets, Unomedical takes these matters seriously and is actively engaging with the FDA to resolve the matters identified as soon as possible.

Contacts

Customer enquiries: cic@convatec.com  

Media: mediarelations@convatec.com 

Analysts & investors: ir@convatec.com 

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com.