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Duckworth & Kent

DUCKWORTH AND KENT LIMITED · Model 2-835E · UDI-DI 05055313831785

HNR

510(k) clearances

861

Adverse events

Recalls

279

Facilities

Description

SMILE Forceps

Recalls

Date	Firm	Reason
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.