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Richard Wolf GmbH · Model 8840712 · UDI-DI 04055207021019

HIF
10
510(k) clearances
7,600
Adverse events (34 deaths)
29
Recalls
141
Facilities

Description

HF KNIFE Ø 4.5MM WL 433MM left-handed, curved, with ceramic insulation, with monopolar HF connection, TL 486mm, reusable

Recalls

DateFirmReason
2026-06-16Olympus Corporation of the AmericasPotential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.

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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.