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Harmonic ACE

ETHICON ENDO-SURGERY, LLC · Model HAR36 · UDI-DI 10705036014447

LFL Prescription
10
510(k) clearances
68,850
Adverse events (81 deaths)
109
Recalls
141
Facilities

Description

Harmonic Ace 5mm Diameter Shears 36cm Shaft length + Adaptive Tissue Technology for use with Generator G11

Recalls

DateFirmReason
2026-03-06Integra LifeSciences Corp. (NeuroSciences)Software issue that renders the touch screen unresponsive.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.

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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.