Class 2 Device Recall HexaVue Focus

• Date Initiated by Firm: September 23, 2026
• Date Posted: October 07, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0118-2027
• Recall Event ID: 99856
• Product Classification: Light, surgical, accessories - Product Code FTA
• Product: HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18
• Code Information: Lot Code: UDI: 00724995245047; Serial Numbers: RL25293001 RL25301003 RL25301004 RL26007031 RL26013044 RL26013045 RL26028062 RL26040066 RL26054029 RL26062001 RL26063005 RL26063007 RL26063013 RL26063014 RL26063019 RL26063021 RL26063022 RL26063023 RL26069033 RL26069034 RL26072049 RL26072052 RL26072053 RL26072055 RL26072056 RL26072056 RL26077072 RL26077073 RL26077074 RL26083077 RL26084078 RL26084080 RL26084081 RL26085083 RL26085084 RL26085085 RL26085086 RL26085087 RL26085088 RL26085089 RL26089090 RL26089091 RL26089092 RL26089093 RL26089094 RL26089095 RL26089096 RL26089097 RL26098098 RL26104099 RL26105102 RL26133103 RL26133104 RL26138105 RL26139106 RL26140114 RL26187116 RL26243121
• FEI Number: 1527821
• Recalling Firm/ Manufacturer: Steris Corporation; 5960 Heisley Rd; Mentor OH 44060-1834
• For Additional Information Contact: Michelle LaVan; 440-2597417
• Manufacturer Reason for Recall: A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.
• FDA Determined Cause: Software design
• Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 9/9/26 was sent to customers. User Action Users can continue to use their integration system(s) prior to completion of the correction, but should confirm that manually printed images are correctly labeled prior to clinical use, filing or scanning into a patient record, distribution or other reliance upon the printed output. Customers should consider reviewing any manually printed images generated using software version 2.0.18 if they have reason to believe the manual print workflow described in this notice may have occurred. Prior to your system(s) receiving the updated software, if you are utilizing the manual printing functionality and have questions regarding the issue described in this notice or interim mitigation measures, please contact STERIS ORI Support at ORI@STERIS.com, or at 800-548-4873. Users are reminded to report any adverse events via FDA s MedWatch Database or local competent authority should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers.
• Quantity in Commerce: 58 systems
• Distribution: Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.