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Rumex

RUMEX INTERNATIONAL CORP. · Model 4-0312S · UDI-DI 00840159900321

HNR
10
510(k) clearances
904
Adverse events
16
Recalls
281
Facilities

Description

Microcoaxial Capsulorhexis Forceps, Ultra Thin, 11.00 mm Curved Jaws, For 2.00 mm Incision, With Alignment Mechanism, Length 106 mm, Stainless Steel

Recalls

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