CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
MST ArcDUO recalled by MicroSurgical Technology
MicroSurgical Technology is recalling MST ArcDUO, distributed nationwide in the US. The recall was initiated on 20 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0411-2026
- FDA event ID
- 97470
- Recalling firm
- MicroSurgical Technology, Redmond, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Aug 2025
- FDA classified
- 29 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Aug 2025 | Recall initiated by company | |
| 29 Oct 2025 | Classified by FDA | +70 days |
| 5 Nov 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Where it was distributed
US Nationwide distribution in the state of GA.
Questions about this recall
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
Which lots are affected?
UDI:00844685014316. Lots: 207552 and 208238
Where was it sold?
US Nationwide distribution in the state of GA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from MicroSurgical Technology
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|---|---|---|---|---|---|
| Device | CLASS II | Reusable Handle for Single Use Heads (Forceps and Scissors) recalled | MicroSurgical Technology | Packaging Defects | 5 states |
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