> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Tracking Sterigenics Closure Impact
- URL: https://www.fdaweb.com/fda-tracking-sterigenics-closure-impact/
- Published: 2019-02-27T12:00:00.000Z
- Updated: 2026-09-15T01:08:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143487

FDA says it is monitoring the impact on medical device supply issues and potential shortages arising from a seal order issued by the Illinois Environmental Protection Agency to the Sterigenics Willowbrook product sterilization facility that resulted in the facility ceasing operations. An online CDRH [message](http://app.info.fda.gov/e/es?s=2027422842&e=189590&elqTrackId=78D8A052C380BCBFF284D754BEBE9730&elq=44ff8f8314b748b4865f231e941cd81b&elqaid=6926&elqat=1&ref=fdaweb.com) says medical devices accounted for over 90% of the products that the Willowbrook facility sterilized. “At this time, FDA believes that more than 100 manufacturers and hundreds of devices may be affected,” the notice says.

The agency says it is not currently aware of any device shortages and can identify strategies to limit or mitigate patient impact due to device supply interruptions.

The notice includes instructions for affected PMA and 510(k) holders to contact FDA under specified circumstances.