Recall Z-0411-2026 ยท HNN Knife, Ophthalmic
MicroSurgical Technology Inc
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
| Date | Oct 29, 2025 (initiated Aug 20, 2025) |
| Status | Open, Classified |
| 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 |
| Root cause | Material/Component Contamination |
| 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 MSTcomplaints@microsurgical.com |
| Quantity | 8 |
| Distribution | US Nationwide distribution in the state of GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.