Class 2 Device Recall MST ArcDUO

• Date Initiated by Firm: August 20, 2025
• Date Posted: October 29, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0411-2026
• Recall Event ID: 97470
• Product Classification: Knife, ophthalmic - Product Code HNN
• Product: MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
• Code Information: UDI:00844685014316. Lots: 207552 and 208238
• FEI Number: 3019924
• Recalling Firm/ Manufacturer: MicroSurgical Technology Inc; 8415 154th Ave Ne; Redmond WA 98052-6482
• For Additional Information Contact: Mei Huang; 425-556-0544
• Manufacturer Reason for Recall: An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
• FDA Determined Cause: Material/Component Contamination
• Action: On 8/20/2025, a recall notice was sent to a surgery center that was asked to return the affected devices and provide information on affected device disposition. The customer was also asked, if they further distributed affected devices, to notify their customers of the recall For additional information, contact the firm at MSTcomplaints@microsurgical.com
• Quantity in Commerce: 8
• Distribution: US Nationwide distribution in the state of GA.
• 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.