Single-Use Reprocessed Ultrasonic Surgical Instruments

FDA product code NLQ · Unclassified · General, Plastic Surgery

Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

27510(k) clearances
0PMA approvals
7recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…NLQ · Traditional Stryker Sustainability Solutions08/14/2025SE
K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…NLQ · Special Stryker Sustainability Solutions07/03/2024SE
K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional Stryker Sustainability Solutions02/20/2024SE
K202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisNLQ · Traditional Stryker Sustainability Solutions03/16/2021SE
K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsNLQ · Traditional Surgical Instrument Service and Savings Inc.(Dba…08/19/2020SE
K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional Sterilmed, Inc.08/15/2019SE
K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional Sterilmed, Inc.04/15/2019SE
K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional Surgical Instrument Service and Savings, Inc.07/12/2018SE
K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional Surgical Instrument Service and Savings Inc.(Dba…07/03/2017SE
K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional Stryker Sustainability Solutions04/05/2017SE
K161693Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisNLQ · Traditional Stryker Sustainability Solutions02/23/2017SE
K151405Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue TechnologyNLQ · Traditional Surgical Instrument Services and Savings(Dba…01/26/2016SE
K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologyNLQ · Traditional Surgical Instrument Services and Savings, Inc.12/16/2015SE
K143562Reprocessed Cordless Ultrasonic Dissection DeviceNLQ · Traditional Sterilmed, Inc.05/20/2015SE
K132566Reprocessed Harmonic ShearNLQ · Traditional Sterilmed, Inc.06/14/2014SE
K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyNLQ · Traditional Stryker Sustainability Solutions05/01/2014SE
K124033Medisiss Reprocessed Ultrasonic InstrumentsNLQ · Traditional Surgical Instruments Service and Savings, Inc.01/07/2014SE
K111794Reprocessed Harmonic ScalpelNLQ · Traditional Sterilmed, Inc.01/11/2012SE
K100537Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9…NLQ · Traditional Ascent Healthcare Solutions05/12/2010SE
K093702Reprocessed Ultrasonic Coagulating ShearsNLQ · Traditional Ascent Healthcare Solutions03/04/2010SE
K083060Reprocessed Harmonic ScalpelNLQ · Traditional Sterilmed, Inc.01/09/2009SE
K043358Reprocessed Ultrasonic ScalpelsNLQ · Traditional Alliance Medical Corp.06/06/2005SE
K050343Reprocessed Harmonic ScalpelsNLQ · Traditional Sterilmed, Inc.04/12/2005SE
K043315Vanguard Reprocessed Hand-Activated Ultrasonic ScalpelNLQ · Traditional Vanguard Medical Concepts, Inc.03/22/2005SE
K043225Vanguard Reprocessed Ultrasonic ScalpelNLQ · Traditional Vanguard Medical Concepts, Inc.03/22/2005SE
K030598Medisiss Reprocessed Ultrasonic Surgical InstrumentsNLQ · Traditional Medisiss01/23/2004SE
K012571Reprocessed HarmonicNLQ · Traditional Sterilmed, Inc.11/07/2001SE

Recalls

RecallProductFirmInitiated
Z-0490-2026 Class IIHARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed…Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in… Stryker Sustainability Solutions09/24/2025Open, Classified
Z-3095-2024 Class IIMedline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only…Potential for an incomplete seal on the packaging tray. MEDLINE INDUSTRIES, LP - Northfield05/07/2024Open, Classified
Z-0120-2024 Class IIMEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1…Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the… MEDLINE INDUSTRIES, LP - Northfield08/03/2023Open, Classified
Z-1327-2021 Class IIStryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7…Product was distributed without receiving regulatory clearance. Stryker Sustainability Solutions01/19/2021Open, Classified
Z-2484-2018 Class IIReprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item…Stryker Sustainability Solutions has received an increase in reports indicating that the affected… Stryker Sustainability Solutions05/08/2018Terminated
Z-1644-2013 Class IIHarmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White)…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… Surgical Instrument Service And Savings, Inc.05/03/2013Terminated
Z-0559-2009 Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… Sterilmed Inc08/08/2008Terminated