MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
This recall is currently active, issued October 29, 2025. It was issued by Microsurgical Technology Inc.
- Company
- Microsurgical Technology Inc
- Recall Initiated
- August 20, 2025
- Posted
- October 29, 2025
- Recall Number
- Z-0411-2026
- Quantity
- 8
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
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
Distribution
US Nationwide distribution in the state of GA.
Lot / Code Info
UDI:00844685014316. Lots: 207552 and 208238
Root Cause
Material/Component Contamination
Action Taken
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