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# Issues at Italy’s Steril Milano Sterilization Facility
- URL: https://www.fdaweb.com/issues-at-italys-steril-milano-sterilization-facility/
- Published: 2021-06-02T12:00:00.000Z
- Updated: 2026-09-14T17:01:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149453

FDA says it is aware of sterility issues with medical devices processed at the Steri Milano SRL Reggiolo and Monza ethylene oxide sterilization facilities in Italy. “FDA became aware that Steril Milano falsified graphs and parameters of sterilization certificates for a variety of FDA regulated products, dating back to 2016,” an agency [notice](https://www.fda.gov/medical-devices/industry-medical-devices/sterility-issues-medical-devices-processed-steril-milano-facilities-letter-industry?utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

The notice says FDA is working with medical device manufacturers, international partners, and U.S. federal partners to investigate the scope of medical devices that may be affected and intends to contact potentially affected firms that are known to have contracted medical device sterilization services with the Steril Milano facilities.

“FDA believes that 97 medical device manufacturers may be affected,” the notice says. “The types of medical devices that may be affected include biopsy needles, catheters, intravascular administration sets, arthroscopes, syringes, and other medical devices. The … facilities were closed 3/2021 and are no longer sterilizing medical devices.”

As of 6/1, FDA says, 10 firms have recalled their affected medical devices.