RegWardenFDA facility compliance records
Recall

Class II — MicroSurgical Technology Inc

Recalling firmMicroSurgical Technology
Registered facilityMICROSURGICAL TECHNOLOGY, INC. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonAn ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
ProductMST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Quantity8
DistributionUS Nationwide distribution in the state of GA.
Initiated2025-08-20
Classified2025-10-29
Recall numberZ-0411-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — MicroSurgical Technology Inc (Z-0411-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97470/

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