Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Italian Sterilization Firm Falsified Certificates Since 2016; 97 Device Makers May Be Impacted, FDA Warns

Executive Summary

Biopsy needles, catheters, intravascular administration sets, arthroscopes and syringes are just a few of the products affected by the deception, some of which have already been recalled. The Steril Milano S.R.L. Reggiolo and Monza ethylene oxide sterilization facilities were shuttered in March.

You may also be interested in...

Steril Milano EtO Deception: FDA Justifies 9-Day Gap From Import Detention To Industry Alert

If the US FDA knew Steril Milano S.R.L. was falsifying ethylene oxide (EtO) certificates on 24 May, why did nine days pass before the agency alerted all of industry? The FDA explains the choice to Medtech Insight.

Reminder: Time’s Running Out To Comment On FDA’s Draft Quality Management System Regulation

The deadline is 24 May to comment on one of the biggest regulatory changes in the history of the US FDA’s device center.

Toxins In Silicone Tubing Leads To FDA Warning About Hemodialysis Machines Made By Fresenius

Toxins that have been shown to cause adverse events in animals – including endocrine dysfunction and male reproductive effects – are emitted by tubing that’s part of Fresenius’ 2008T, 2008K2 and 2008K model devices, the US agency says in a letter to health care providers.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts