FDA Medical devices recall ·
MST ArcDUO 9mm recall
- Recall number
- Z-0411-2026
- Date
- (initiated August 20, 2025)
- Company / brand
- MicroSurgical Technology Inc
8415 154th Ave Ne, Redmond, WA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Why was it 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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI:00844685014316. Lots: 207552 and 208238
Distribution
US Nationwide distribution in the state of GA.
States: Georgia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0411-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.