MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
FDA device recall Z-0411-2026 · posted 2025-10-29 · Open, Classified
Recall details
- Recalling firm
- MicroSurgical Technology Inc
- 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
- Action taken
- 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 MSTcomplaints@microsurgical.com
- Root cause
- Material/Component Contamination
- Status
- Open, Classified
- Product code
- HNN
- Quantity affected
- 8
- Distribution
- US Nationwide distribution in the state of GA.
- Date initiated
- 2025-08-20
- Date posted
- 2025-10-29
- Location
- Redmond, WA
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