Recall Z-0411-2026— MicroSurgical Technology Inc

Name: FDA recall Z-0411-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-20

Class II · Ongoing

Class II FDA medical device recall by MicroSurgical Technology Inc, initiated 2025-08-20. FDA's recall record names no specific 510(k) clearance for this event. 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.

Recalling firm: MicroSurgical Technology Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-08-20
Firm location: Redmond, WA, United States

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.