MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile… recallZ-0411-2026 · MicroSurgical Technology Inc · initiated Aug 20, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MicroSurgical Technology Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Material/Component Contamination
What the company is doing
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]
Recall details
- Recall number
- Z-0411-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 20, 2025
- Posted by the FDA
- Oct 29, 2025
- Recalling firm
- MicroSurgical Technology Inc
- Quantity
- 8
- Product code
- HNN
- Distribution
- US Nationwide distribution in the state of GA.
Product description
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Code information (models, lots, serial numbers)
UDI:00844685014316. Lots: 207552 and 208238
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ArcDuo, Guarded Depth Paired Ophthalmic Knife 9mm ARC-0002Microsurgical Technology, Inc. · Knife, Ophthalmic1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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