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Millennium

Avalign Technologies, Inc. · Model 92-F2501 · UDI-DI 00190776397579

HNR
10
510(k) clearances
888
Adverse events
16
Recalls
281
Facilities

Description

Gimbel Capsulorhexis Forceps, jaws set to open only 3mm, angled 12mm from bend to tip, extremely thin triangular grasping tips, serrated flat handle, 80mm OL, 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, 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.

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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.