MST ArcDUO 9mm — Class II medical device recall Z-0411-2026
Ongoing recall by MicroSurgical Technology Inc, reported 2025-11-05, distributed nationwide. An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated wit
| Recall number | Z-0411-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MicroSurgical Technology Inc, Redmond, WA, United States |
| Recall initiated | 2025-08-20 |
| Classified | 2025-10-29 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 8 |
| UPC / GTIN / UDI-DI | 00844685014316 |
| Lot numbers | 207552, 208238 |
| Model numbers | 48-1000-01, ARC-0002 |
Product
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0411-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.