Friday, Steris Corp. (STE) said that it was notified on December 3 that the United States Food and Drug Administration or FDA had issued a notice to healthcare facility administrators regarding the regulatory status of the Steris SYSTEM 1 Sterile Processing System, as well as actions healthcare facilities should take if they use this device.
In its warning letter, the FDA had stated that healthcare administrators should transition to acceptable alternatives to meet their sterilization and decontamination requirements. If they do not have an acceptable alternative, FDA has stated that customers may continue to use SYSTEM 1 while they assess their sterilization requirements. FDA has also stated it is not aware of any confirmed cases of infection directly attributable to inadequate reprocessing by SYSTEM 1.
"We disagree with the FDA's recent notice and are working to engage in further dialogue with the Agency about this matter. Since its introduction in 1988, we estimate that the SYSTEM 1 Sterile Processing System has safely and effectively sterilized more than 300 million devices when used as directed," said Walt Rosebrough, Steris president and chief executive officer.
Steris said that when considering the availability of acceptable alternatives to meet sterilization and disinfection needs, healthcare administrators should consult the device manufacturer's written instructions for reprocessing procedures. The company also said that healthcare administrators should be aware that not all devices can be reprocessed using the same sterilization technology, and note that the healthcare facility's validation/verification requirements will need to be reviewed.
Mentor, Ohio-based Steris said that as a result of the December 3, notice, it is considering its available options and expects to have further discussions with the FDA. There is no assurance, however, that the FDA will not pursue an administrative or enforcement action or not seek other remedies, including the demand that Steris stop further sales of the SYSTEM 1 device and any related services, accessories and sterilant.
According to the company, these actions by the FDA could possibly result in administrative orders or judgments requiring re-labeling or restriction on the manufacturing, sale, or distribution of products, or could require us to take other actions, including recalls, to pay significant monetary fines or civil damages, or to be subject to other governmental or third party claims or remedies, which could materially affect our business, performance, value, financial condition, and results of operations.
STE closed Friday's last trade on the New York Stock Exchange at $29.14, down $4.17 or 12.52%. In the after hours the stock traded down $0.15 or 0.51%.
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