Medical device recalls Moderate risk

MicroSurgical Technology Inc recalls MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

Recall date
August 20, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0411-2026
FDA classification
Class II
Brand / firm
MicroSurgical Technology Inc
Sold / distributed
US Nationwide distribution in the state of GA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

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