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CLASS II · ModerateFDA

MicroSurgical Technology Inc recalls MST ArcDUO 9mm

📅 Aug 20, 2025 · 📍 Nationwide
Recalling company
MicroSurgical Technology Inc
Product
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Reason
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
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Aug 20, 2025
Reported
Nov 5, 2025
Distribution
US Nationwide distribution in the state of GA.
Status
Ongoing
Quantity
8
Lot / codes
UDI:00844685014316. Lots: 207552 and 208238
Company location
Redmond, WA
Recall type
Voluntary: Firm initiated
Recall number
Z-0411-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0411-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.