The Recall Desk
ModerateFDA (Devices)·Z-0411-2026·Announced 2025-11-05

Ophthalmic knife suction sets recalled over residue on internal springs

MicroSurgical Technology is recalling eight MST ArcDUO 9mm ophthalmic knives because springs in the accompanying suction set carry an unidentified residue that may cause eye irritation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 as low-risk contamination: the residue is on a component the record states is not directly patient-contacting, and the only stated consequence is eye irritation.

Plain-English summary

The MST ArcDUO 9mm, REF ARC-0002, a single-use sterile ophthalmic knife used with Suction Set part 48-1000-01, is being recalled by MicroSurgical Technology.

The firm states the suction set, which is not directly patient-contacting, contains springs contaminated with an unidentified residue that may potentially cause eye irritation.

The recall covers 8 units carrying UDI 00844685014316, from lots 207552 and 208238, distributed in Georgia. The FDA has classified the action as Class II.

The enforcement record describes the residue and reports no injuries. Facilities holding the affected lots should follow the firm's instructions.

The recalled product

Product
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Manufacturer
MicroSurgical Technology Inc
Category
Medical Device — Ophthalmic instrument
Hazard
  • residue
  • contamination
  • ophthalmic

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI:00844685014316. Lots: 207552 and 208238

Distribution

Distributed nationwide across the United States.

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