Instrument, Ultrasonic Surgical
Unknown
Recent MDR events
68,052 adverse event reports on file
- Harmonic ACEJul 31, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-06038
- Harmonic ACEJul 31, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-06044
- Instrument, Ultrasonic SurgicalJul 31, 2026MalfunctionJohnson & Johnson Medical (suzhou) Ltd.3005075853-2026-06046
- HarmonicJul 31, 2026MalfunctionJohnson & Johnson Medical (suzhou) Ltd.3005075853-2026-06047
- HarmonicJul 31, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-06048
- HarmonicJul 31, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-06049
- Harmonic ACEJul 31, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-06051
- HarmonicJul 31, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-06052
- HarmonicJul 31, 2026MalfunctionJohnson & Johnson Medical (suzhou) Ltd.3005075853-2026-06053
- HarmonicJul 31, 2026MalfunctionEthicon Endo-surgery, Llc.3005075853-2026-06054
Event type breakdown
Most-reported manufacturers
Recalls
109 recall events for this product code
- Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedApr 17, 2026
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Software issue that renders the touch screen unresponsive.
Z-1828-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 17, 2026
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Z-1371-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 17, 2026
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Z-1372-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 17, 2026
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Z-1373-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 17, 2026
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Z-1374-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 17, 2026
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Z-1375-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 17, 2026
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Z-1376-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 17, 2026
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
Z-1377-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 17, 2026
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
Z-1378-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 17, 2026
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Z-1379-2026 · View FDA record ↗
Registered firms
389 firms currently registered for this product code
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Cankaya Ankara, TR
Medtronic Distribution Center
Memphis, TN, US
Ethicon Endo-surgery, Inc.
Cincinnati, OH, US
Intuitive Surgical, Inc.
Santa Clara, CA, US
Ethicon Endo-surgery, Llc
GUAYNABO, PR, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Covidien
Lafayette, CO, US
Sterigenics Us Llc
Los Angeles, CA, US
Sterigenics Us Llc
Grand Prairie, TX, US
Sterigenics U.s., Llc
Atlanta, GA, US
Linemaster Switch Corp.
WOODSTOCK, CT, US
Sterigenics U.s., Llc
Santa Teresa, NM, US
Dsv Solutions Ltd.
Brinklow Milton Keynes, GB
Medineedle - Rescue Group Rettungsdienst
Wolpertshausen Bavaria, DE
Pmc Smart Solutions, Llc
Shelbyville, IN, US
Ethicon Endo-surgery S.a. De C.v. Planta Ii
CIUDAD JUAREZ Chihuahua, MX
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi
Istanbul, TR
Shirakawa Olympus Co., Ltd.
NISHISHIRAKAWA-GUN Fukushima, JP
Synergy Health Ast, Llc
SAN DIEGO, CA, US
Bioventus Llc
Cordova, TN, US
Trice Medical
Malvern, PA, US
510(k) clearances
158 clearances for this product code
- Misonix, LLCJul 30, 2026
K261448 · neXus Ultrasonic Surgical Aspirator System
- Integra LifeSciences CorporationOct 8, 2025
K251162 · CUSA® Clarity Ultrasonic Surgical Aspirator System
- Shanghai Saints Sages Surgical Co., Ltd.Jun 18, 2025
K242894 · SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
- Stryker InstrumentsMar 24, 2025
K243930 · Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
- Trice Medical, Inc.Nov 18, 2024
K241700 · Tenex 2nd Generation System
- Integra LifeSciences CorporationJul 11, 2024
K240493 · CUSA® Clarity Ultrasonic Surgical Aspirator System
- Hunan Handlike Minimally Invasive Surgery Co., Ltd.Jun 18, 2024
K233036 · Ultrasonic Surgical System
- Integra LifeSciences CorporationJul 11, 2023
K230427 · CUSA Clarity Ultrasonic Surgical Aspirator System