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Open, Classified

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

FDA Recall Z-0411-2026 · Posted 2025-10-29

Recalling FirmMicroSurgical Technology Inc
Recall StatusOpen, Classified
Product CodeHNN
Date Initiated2025-08-20
Product Quantity8

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

Firm Action

On 8/20/2025, a recall notice was sent to a surgery center that was asked to return the affected devices and provide information on affected device disposition. The customer was also asked, if they further distributed affected devices, to notify their customers of the recall For additional information, contact the firm at [email protected]

Root Cause

Material/Component Contamination

Distribution Pattern

US Nationwide distribution in the state of GA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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