FDA recall Z-0411-2026

MicroSurgical Technology Inc · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2025-08-20
Report date
2025-11-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0411-2026